M Pharm Regulation & Syllabus

Regulations and Curriculum for
Master of Pharmacy
M.Pharm
(Semester Scheme)
Amended up to 2019-20
(Deemed to be University under Section 3 of UGC Act, 1956)

(Placed under Category ‘A’ by MHRD, Govt. of India, Accredited with ‘A’ Grade by NAAC)
University Enclave, Deralakatte, Mangalore – 575 018
Tel: +91-824-2204300/01/02/03, Fax: 91-824-2204305
Website: www.nitte.edu.in E-mail: info@nitte.edu.in
Regulations and Curriculum –M.Pharm
VISION
To build a humane society through excellence in education and healthcare
MISSION
To develop
Nitte (Deemed to be University)
As a centre of excellence imparting quality education,
generating competent, skilled manpower to face the scientific and social
challenges with a high degree of credibility, integrity,
ethical standards and social concern
Contents
Page No.
Notifications iii - vi
Regulations 1 - 35
Preamble
Introduction
Definitions
Minimum qualification for admission
Duration of the program
Medium of instruction and examinations
Maximum Period for completion of the course
Selection of eligible candidates
Withdrawal – Temporary and Permanent
Conduct and discipline
Working days in each semester
Attendance and Monitoring Progress of Students
Program/Course credit structure
Academic work
Course of study
Program Committee
Examinations / Assessments
Promotion and award of grades
Carry forward of marks
Improvement of internal assessment
Re-examination of end semester examinations
Allowed To Keep Terms (ATKT)
Grading of performances
The Semester Grade Point Average (SGPA)
Cumulative Grade Point Average (CGPA)
Declaration of Results and Classification
Project work
Dissertation
Graduation Requirements
Award of Ranks
Award of degree
Revaluation / Retotaling of answer papers
Supplementary Examination
i
Re-admission after break of study

Convocation
Guidelines for pharmacy students for carrying
out industrial projects in partial fulfillment of
M.Pharm degree 36 - 37
Syllabus for M.Pharm in various Specialties
Pharmaceutics 38 - 58
Pharmaceutical Chemistry 59 - 82
Pharmaceutical Quality Assurance 83 - 106
Pharmaceutical Regulatory Affairs 107 - 131
Pharmacy Practice 132 - 152
Pharmacology 153 - 178
Syllabus for III Semester - Research Methodology
& Biostatistics for all branches 179 - 180
ii
No. F.9-13/2007-U.3 (A)
Government of India
Ministry of Human Resource Development
(Department of Higher Education)
U.3(A) Section
Shastri Bhavan, New Delhi

Dated: 4th Jun, 2008
NOTIFICATION
1. Whereas the Central Government is empowered under Section 3 of the

University Grants Commission (UGC) Act, 1956 to declare, on the advice of
the UGC, an institution of higher learning as a deemed-to-be-university;
2. And whereas, a proposal was received in February, 2007 from Nitte Education
Trust, Mangaluru, Karnataka seeking grant of status of deemed-to-be university
in the name of Nitte (Deemed to be University) under section 3 of the UGC
Act, 1956;
3. And whereas, the University Grants Commission has examined the said
proposal and vide its communication bearing No. F.26-10/2007(CPP-I/DU),
dated the 10th March, 2008 has recommended conferment of status of ‘deemed-
to-be-university’ in the name and style of Nitte (Deemed to be University),
Mangaluru, Karnataka, comprising A. B. Shetty Memorial Institute of Dental
Sciences, Mangaluru.
4. Now, therefore, in exercise of the powers conferred by section 3 of the UGC
Act, 1956, the central Government, on the advice of the University Grants
Commission (UGC), hereby declare that Nitte (Deemed to be University),
Mangaluru, Karnataka, comprising A. B. Shetty Memorial Institute of Dental
Sciences, Deralakatte, Mangaluru, shall be deemed to be a University for the
Purposes of the aforesaid Act.
Sd/
(Sunil Kumar)
Joint Secretary to the Government of India
(True Extract of the Notification)
iii
University Grants Commission
Bahadurshah Zafar Marg
New Delhi – 110002
No. F.26-5/2008(CPP-1) Dated: 24th March, 2009
OFFICE MEMORANDUM
1. Whereas the Government of India, Ministry of Human Resource

Development, Department of Higher Education vide Notification No. F.9-
13/2007-U3(A) dated 4th June, 2008 declared Nitte (Deemed to be
University), Mangaluru, Karnataka comprising A. B. Shetty Memorial
Institute of Dental Sciences, Deralakatte, Mangaluru as Deemed to be
University under Section 3 of UGC Act, 1956.
2. And whereas now, the University Grants Commission, on the
recommendation of an Expert Committee constituted by the Chairman, UGC
has agreed for bringing (i)K. S. Hegde Medical Academy, Deralakatte,
Mangaluru (ii) Nitte Usha Institute of Nursing Sciences, Deralakatte,
Mangaluru (iii) Nitte Gulabi Shetty Memorial Institute of Pharmaceutical
Sciences, Deralakatte, Mangaluru, (iv) Nitte Institute of Physiotherapy,
Deralakatte, Mangaluru under the ambit of Nitte (Deemed to be University),
Deralakatte, Mangaluru.
Sd/
(K. P. Singh)
Joint Secretary, University Grants Commission
(True Extract of the Office Memorandum)
iv
(Established under Section 3 of UGC Act, 1956)
Placed under Category ‘A’ by MHRD, Govt. of India
Accredited with ‘A’ Grade by NAAC
Ref. No. NU/REG/AC/2016-17/655 Date: 20.03.2017
NOTIFICATION
Subject: Regulations and Curriculum pertaining to Master of Pharmacy

Reference: Minutes of the 31st Academic Council meeting held on 14.03.2017
In exercise of the Powers conferred under Rule R-08 (g) of the Memorandum of
Association, the Academic Council has been pleased to approve the Regulations and
Course Curriculum for the M.Pharm Course as per the All India Council for
Technical Education (AICTE) and Pharmacy Council of India (PCI) norms in the
Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences.
The Regulations and course curriculum shall come into force from the academic year
2017- 18.
By Order,
Registrar
v
(Established under Section 3 of UGC Act, 1956)
Placed under Category ‘A’ by MHRD, Govt. of India
Accredited with ‘A’ Grade by NAAC
Ref: NU/REG/AC-NGSMIPS/2018-19/371 Date: 01.12.2018
NOTIFICATION
Sub: Guidelines for the change of pharmacy PG specialization.

In exercise of the powers conferred under Rule No. R.9 of the MOA, the Academic
Council in its 37th meeting held on 20.11.2018 under the agenda item no. AC/4-
37/18 is pleased to approve the guidelines for change of pharmacy PG specialization
from the Academic Year 2019-20.
By Order,
REGISTRAR
University Enclave, Medical Sciences Complex, T 0824-2204300/01/02/03 E reg@nitte.edu.in

Deralakatte, Mangalore – 575 018 D 0824-2204309 W www.nitte.edu.in
F 0824-2204305
vi
(Deemed to be University under Section 3 of UGC Act, 1956)

(Placed under Category ‘A’ by MHRD, Govt. of India, Accredited with ‘A’ Grade by NAAC)
Mangalore, Karnataka, India
Regulations and Curriculum for

Master of Pharmacy (M.Pharm)
(Amended up to 2019-20)
Preamble:
Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, imparting
education and training in pharmaceutical sciences since 1983, started B. Pharm
program in 1984. M.Pharm programs were introduced in 1991. From the year 2009-
10 the Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences became a
constitute college of Nitte (Deemed to be University). The Pharm.D program was
started in the year 2012-13. Consequent to introducing semester system for M.Pharm
program as per PCI course regulations 2014, the new regulations are formulated as
under:
1. Introduction
1.1. These regulations shall be called as revised regulations for the M.Pharm
degree program of Nitte (Deemed to be University). The Regulations for
M.Pharm program shall govern the policies and procedures including
selection, admission, imparting of instructions, conduct of examinations,
evaluation and certification of candidate’s performance and all
amendments there to, leading to the award of M.Pharm degree. The
regulations are in conformance with “The Revised Regulations for
M.Pharm. degree program of Pharmacy Council of India” and All India
Council for Technical Education (AICTE) regulations of Master of
Pharmacy (M.Pharm) degree program.
1.2. This set of regulations shall be binding on all the candidates undergoing
the said degree programme. The regulations shall come into effect from the
academic year 2019-20.
1.3. These regulations may be modified from time to time as mandated by the
statutes of the University, the AICTE and the PCI.
1.4. This set of regulations may evolve and get refined or updated or amended
or modified or changed through appropriate approvals from the Academic
1
Council or the Board of Management from time to time and shall be

binding on all parties concerned including the candidates, faculty, staff,
departments and institute authorities.
1.5. All disputes arising from this set of regulations shall be addressed to the
Board of Management. The decision of the Board of Management is final
and binding on all parties concerned. Further, any legal disputes arising out
of this set of regulations shall be limited to the jurisdiction of Courts of
Mangaluru only.
2. Definitions:
Unless the context otherwise requires
 Academic Year means two consecutive (one odd + one even) semesters
 BOM means Board of Management of Nitte (Deemed to be University)
 BOS means Board of Studies in Pharmaceutical Sciences
 College/Institution means Nitte Gulabi Shetty Memorial Institute of
Pharmaceutical Sciences
 He includes both genders He and She; similarly his and / or him, himself
includes her, as well in all cases
 Head of the Institution means the Principal of the College (Nitte Gulabi
Shetty Memorial Institute of Pharmaceutical Sciences)
 Regulations means this set of academic regulations
 Regulatory Authority – Authority appointed / constituted by the central /
state government/s to regulate Pharmaceutical Sciences Education
 University means Nitte (Deemed to be University)
 Program means a set of courses which the student has to complete for the
award of M.Pharm. degree
 Course means a subject or a paper. A course may comprise either theory
or practical listed under the program
 Credit means a unit by which the course work is measured. It determines
the number of hours of instructions required per week. One credit is
equivalent to one hour of teaching (lecture)/journal club/research work
presentation/discussion with supervisor or two hours of research
work/practical/seminar/assignment/ project work per week.
 Semester Grade Point Average (SGPA) means a measure of performance
of work done in a semester. It is ratio of total credit points secured by a
student in various courses registered in a semester and the total course
2
credits taken during that semester. It shall be expressed up to two decimal

places
 Cumulative Grade Point Average (CGPA) means a measure of overall
cumulative performance of a student over all semesters. The CGPA is the
ratio of total credit points secured by a student in various courses in all
semesters and the sum of the total credits of all courses in all the
semesters. It is expressed up to two decimal places.
 Letter Grade is an index of the performance of a candidate in a said course.
Grades are denoted by letters O, A, B, C, D, F and AB.
 Grade Point means a numerical weight allotted to each letter grade on a
10-point scale.
 IA means Internal Assessment comprising of continuous mode and
sessional exams
 ESE means End Semester Examination
3. Minimum qualification for admission

A Pass in the following examination
A candidate seeking admission to M. Pharm course must have a bachelor’s
degree / B.Pharm degree awarded by an Indian University recognized by PCI/
AICTE and who has secured not less than 55% of the maximum marks (aggregate
of four years) prescribed for the qualifying examination shall be eligible for the
admission to the M. Pharm course.
Every student, selected for admission to post graduate pharmacy program in any PCI
approved institution should have obtained registration with the State Pharmacy
Council or should obtain the same within one month from the date of his/her
admission, failing which the admission of the candidate shall be cancelled.
Foreign nationals who have qualified from a foreign university should obtain
permission from the Nitte (Deemed to be University) prior to the admission for
equivalence of the degree.
Note: It is mandatory to submit a migration certificate obtained from the respective university
where the candidate had passed his/her qualifying degree (B.Pharm.)
3
4. Duration of the program

The program of study for M.Pharm shall extend over a period of four semesters
(two academic years). The curricula and syllabi for the program shall be
prescribed from time to time by Pharmacy Council of India, New Delhi.
5. Medium of instruction and examinations

Medium of instruction and examination shall be in English.
6. Maximum Period for completion of the course:

The maximum period for completion of the M.Pharm course is four years.
7. Selection of eligible candidates:

Selection to the M.Pharm course shall be based on the basis of merit obtained in
the qualifying examination.
8. Withdrawal – Temporary and Permanent:

8.1. Temporary withdrawal:
8.1.1. A candidate who has been admitted to the course may be permitted
to withdraw temporarily for a period of six months or more upto
one year on the grounds of prolonged illness, grave calamity in the
family etc., provided:
a) He applied stating the reason of withdrawal with supporting
documents and endorsement by parent / guardian.
b) The Institute is satisfied that without counting the period of
withdrawal candidate is likely to complete his requirement
of the degree within maximum time specified.
c) There are no outstanding dues or demands with the
department, library, hostel, Institute etc.
8.1.2. The tuition fee for the subsequent year may be collected in advance
based on the severity of the case before giving approval for any
such temporary withdrawal.
8.1.3. Scholarship holders are bound by the appropriate rules applicable.
8.1.4. The decision of the Institute / University regarding withdrawal of
a candidate is final and binding.
8.2. Permanent withdrawal:
8.2.1. A candidate who withdraws admission before closing date of
4
admission for the academic session is eligible for the refund of the
deposit only. The fees once paid will not be refunded on any
account.
8.2.2. Once the admission for the year is closed, and if a candidate wants
to leave the Institution, he will be permitted to do so and take the
Transfer Certificate from the institute, if required, only after
remitting all the tuition fees for the remaining years.
8.2.3. Those candidates who have received any scholarship / stipend /
other forms of assistance from the institute shall repay all such
amounts in addition to those mentioned in the clause above.
8.2.4. The decision of the institute / university regarding withdrawal of a
candidate is final and binding.
9. Conduct and discipline:

9.1. Candidates shall conduct themselves within and outside the premises of the
Institute in a manner befitting the student of professional Institution.
9.2. As per the order of Honorable Supreme Court of India, ragging in any
form is considered as a criminal offence and is banned. Any form of
ragging will be severely dealt with.
9.3. The following act of omission and/or commission shall constitute gross
violation of the code of conduct and are liable to invoke disciplinary
measures:
9.3.1. Ragging as defined and described by the Supreme
Court/Government.
9.3.2. Lack of courtesy and decorum; indecent behaviour anywhere
within or outside the campus.
9.3.3. Willful damage or stealthy removal of any property/belongings of
the College/Hostel or of fellow candidates/citizens.
9.3.4. Possession, consumption or distribution of alcoholic drinks or any
kind of hallucinogenic drugs.
9.3.5. Mutilation or unauthorized possession of library books.
9.3.6. Noisy or unseemly behavior, disturbing studies of fellow
candidates.
9.3.7. Hacking in computer systems (such as entering into other person’s
domain without prior permission, manipulation and/or damage to
the computer hardware and software or any other cyber crime etc.)
9.3.8. Plagiarism of any nature.
5
9.3.9. Any other act of gross indiscipline as decided by the Board of

management from time to time.
9.4. Commensurate with the gravity of offense, the punishment may be:
reprimand, fine, expulsion from the hostel, debarment from an examination,
disallowing the use of certain facilities of the Institute, rustication for a
specific period or even outright expulsion from the Institute, or even handing
over the case to appropriate law enforcement authorities or the judiciary, as
required by the circumstances.
9.5. For any offence committed in (i) a hostel (ii) a department or in a
classroom and (iii) elsewhere, the Chief Warden, the Head of the
Department and the Head of the Institution, respectively, shall have the
authority to reprimand or impose fine.
9.6. All cases involving punishment other than reprimand shall be reported to the
Vice- chancellor.
9.7. Cases of adoption of unfair means and/or any malpractice in an examination
shall be reported to the Controller of Examinations for taking appropriate
action.
10. Working days in each semester:

Each semester shall consist of not less than 100 working days. The odd
semesters shall be conducted from the month of July/August to
December/January and the even semesters shall be conducted from the month
of January/February to June/July in every calendar year.
11. Attendance and Monitoring Progress of Students:

A candidate is required to put in at least 80% attendance in individual courses
considering theory and practical separately. The candidate shall complete the
prescribed course satisfactorily to be eligible to appear for the respective
examinations.
11.1 Attendance
11.1.1 A candidate pursuing M.Pharm course shall study in the
concerned Department of the Institution for the entire period as a
full time candidate. No candidate is permitted to work in any
laboratory / Institution / industry / pharmacy, etc., during the
period of study. No candidate should join any other course of
study or appear for any other degree examination conducted by
this university or any other university in India or abroad during
6
the period of registration.

11.1.2 Each semester shall be taken as a unit for the purpose of
calculating attendance.
11.1.3 A student shall attend symposia, seminars, conferences, journal
review meetings, journal club and lectures during each semester
as prescribed by the department / college / university and not
absent himself / herself without valid reason.
11.1.4 A candidate who has put in a minimum of 80% of attendance in
the theory and practical assignments separately and who has
fulfilled all other requirements of the course shall be permitted to
appear for the semester end examination.
11.1.5 Only the candidate who has put in a minimum of 80% of
attendance in II year shall be eligible to submit the dissertation.
11.2 Monitoring Progress of Studies:
11.2.1 A student shall maintain a work diary and record of his
participation in the training programmes such as review of
journal, seminars etc. conducted by the department / institution.
11.2.2 The work diary shall be scrutinized and certified by the Head of
the Department and Head of the Institution, and presented in the
University practical examination.
11.2.3 Special mention may be made of the presentations by the student
as well as details of experiments or laboratory procedures,
conducted by the student.
12 Program/Course credit structure:

As per the philosophy of Credit Based Semester System, certain quantum of
academic work viz. theory classes, practical classes, seminars, assignments, etc.
are measured in terms of credits. On satisfactory completion of the courses, a
candidate earns credits. The amount of credit associated with a course is
dependent upon the number of hours of instruction per week in that course.
Similarly the credit associated with any of the other academic, co/extra-
curricular activities is dependent upon the quantum of work expected to be put
in for each of these activities per week/per activity.
12.1 Credit assignment
Theory and Laboratory courses: Courses are broadly classified as Theory
and Practical. Theory courses consist of lecture (L) and Practical (P)
courses consist of hours spent in the laboratory. Credits (C) for a course
7
is dependent on the number of hours of instruction per week in that

course, and is obtained by using a multiplier of one (1) for lecture and a
multiplier of half (½) for practical (laboratory) hours. Thus, for example,
a theory course having four lectures per week throughout the semester
carries a credit of 4. Similarly, a practical having four laboratory hours
per week throughout semester carries a credit of 2.
The contact hours of seminars, assignments and research work shall be

treated as that of practical courses for the purpose of calculating credits.
i.e., the contact hours shall be multiplied by 1/2. Similarly, the contact
hours of journal club, research work presentations and discussions with
the supervisor shall be considered as theory course and multiplied by 1.
12.2 Minimum credit requirements
The minimum credit points required for the award of M.Pharm degree is
93. A student may earn upto a maximum of 98 credit points including the
5 credit points assigned to co-curricular and extra-curricular activities.
These credits are divided into Theory courses, Practical, Seminars,
Assignments, Research work, Discussions with the supervisor, Journal
club and Co-Curricular activities over the duration of four semesters. The
credits are distributed semester- wise as shown in Table 10. Courses
generally progress in sequence, building competencies and their
positioning indicates certain academic maturity on the part of the
learners. Learners are expected to follow the semester-wise schedule of
courses given in the syllabus.
13 Academic work:
A regular record of attendance both in Theory, Practical, Seminar, Assignment,
Journal club, Discussion with the supervisor, Research work presentation and
Dissertation shall be maintained by the department / teaching staff of respective
courses.
8
14 Course of study:
14.1. The specializations offered in M.Pharm program are listed in Table 1.
Students have to opt for one of the specializations at the time of admission.
14.2. Change of Specialization after admission:
1. Request for change of departments should be made within 15 days
of the commencement of PG programmes which should be
endorsed by the parents.
2. The reason for change should be clearly explained by the student.
3. The NOC from both the department heads should be obtained.
4. There should be vacancy in the department where the student
wishes to join.
5. To avoid such requests, the department heads should conduct
induction/orientation programme for atleast a week to the students
who join the programme explaining the methods, objectives, skills
required etc.. for the program.
6. In case the transfer is approved, the department to which the
student migrates should conduct classes which the student has
missed and maintain relevant records.
7. The last date for withdrawal should be at least 15 days earlier than
the last date of admission with fine, so that the vacancy created can
be filled.
Table – 1: List of M.Pharm. Specializations and their Code

S. No. Specialization Code
1. Pharmaceutics MPH
2. Pharmaceutical Chemistry MPC
3. Pharmaceutical Quality Assurance MQA
4. Pharmaceutical Regulatory Affairs MRA
5. Pharmacy Practice MPP
6. Pharmacology MPL
14.3 The course of study for M.Pharm specializations shall include Semester
wise Theory & Practical as given in Tables 2 to 7. The number of hours to
be devoted to each theory and practical course in any semester shall not
be less than that shown in the tables.
9
Table – 2: Course of study for M. Pharm. (Pharmaceutics)

Course Course Credit Credit Hrs. / Marks
Code Hours Points wk
Semester I
MPH101T Modern Pharmaceutical Analytical
Techniques 4 4 4 100
MPH102T Drug Delivery Systems 4 4 4 100
MPH103T Modern Pharmaceutics 4 4 4 100
MPH104T Regulatory Affair 4 4 4 100
MPH105P Pharmaceutics Practicals I 12 6 12 150
Seminar/Assignment 7 4 7 100
Total 35 26 35 650
Semester II
MPH201T Molecular Pharmaceutics (Nano Tech and
Targeted DDS) 4 4 4 100
MPH202T Advanced Biopharmaceutics &

Pharmacokinetics 4 4 4 100
MPH203T Computer Aided Drug Development 4 4 4 100
MPH204T Cosmetics and Cosmeceuticals 4 4 4 100
MPH205P Pharmaceutics Practical - II 12 6 12 150
Total 35 26 35 650
Table – 3: Course of study for M. Pharm. (Pharmaceutical Chemistry)

Course Course Credit Credit Hrs./ Marks
Semester I
MPC101T Modern Pharmaceutical Analytical
MPC102T Advanced Organic Chemistry -I 4 4 4 100
MPC103T Advanced Medicinal chemistry 4 4 4 100
10
MPC104T Chemistry of Natural Products 4 4 4 100

MPC105P Pharmaceutical Chemistry Practical -I 12 6 12 150
Total 35 26 35 650
Course Credit Credit Hrs./ Marks
Code Course Hours Points wk
Semester II
MPC201T Advanced Spectral Analysis 4 4 4 100
MPC202T Advanced Organic Chemistry -II 4 4 4 100
MPC203T Computer Aided Drug Design 4 4 4 100
MPC204T Pharmaceutical Process Chemistry 4 4 4 100
MPC205P Pharmaceutical Chemistry Practical - II 12 6 12 150
Total 35 26 35 650
11
Table – 4: Course of study for M. Pharm. (Pharmaceutical Quality Assurance)

Semester I
MQA101T Modern Pharmaceutical Analytical
MQA102T Quality Management System 4 4 4 100
MQA103T Quality Control and Quality Assurance 4 4 4 100
MQA104T Product Development and Technology
Transfer 4 4 4 100
MQA105P Pharmaceutical Quality Assurance
Practical I 12 6 12 150
Total 35 26 35 650
Semester II
MQA201T Hazards and Safety Management 4 4 4 100
MQA202T Pharmaceutical Validation 4 4 4 100
MQA203T Audits and Regulatory Compliance 4 4 4 100
MQA204T Pharmaceutical Manufacturing
Technology 4 4 4 100
MQA205P Pharmaceutical Quality Assurance
Practical II 12 6 12 150
Total 35 26 35 650
12
Table – 5: Course of study for M. Pharm. (Pharmaceutical Regulatory Affairs)

Semester I
MRA101T Good Regulatory Practices 4 4 4 100
MRA102T Documentation and Regulatory Writing 4 4 4 100
MRA103T Clinical Research Regulations 4 4 4 100
MRA104T Drugs Regulations and other Legislation in
India and Intellectual Property Rights 4 4 4 100
MRA105P Regulatory Affairs Practical I 12 6 12 150
Total 35 26 35 650
Semester II
MRA201T Regulatory Aspects of Drugs & Cosmetics 4 4 4 100
MRA202T Regulatory Aspects of Herbal &
Biologicals 4 4 4 100
MRA203T Regulatory Aspects of Medical Devices 4 4 4 100
MRA204T Regulatory Aspects of Food &
Nutraceuticals 4 4 4 100
MRA205P Regulatory Affairs Practical II 12 6 12 150
Total 35 26 35 650
13
Table – 6: Course of study for M. Pharm. (Pharmacy Practice)

Semester I
MPP101T Clinical Pharmacy Practice 4 4 4 100
MPP102T Pharmacotherapeutics-I 4 4 4 100
MPP103T Hospital & Community Pharmacy 4 4 4 100
MPP104T Clinical Research 4 4 4 100
MPP105P Pharmacy Practice Practical I 12 6 12 150
Total 35 26 35 650
Course Credit Credit Hrs./
Course Marks
Semester II
MPP201T Principles of Quality Use of Medicines 4 4 4 100
MPP202T Pharmacotherapeutics II 4 4 4 100
MPP203T Clinical Pharmacokinetics and
Therapeutic Drug Monitoring 4 4 4 100
MPP204T Pharmacoepidemiology &
Pharmacoeconomics 4 4 4 100
MPP205P Pharmacy Practice Practical II 12 6 12 150
Total 35 26 35 650
14
Table – 7: Course of study for M. Pharm. (Pharmacology)

Semester I
MPL101T Modern Pharmaceutical Analytical
MPL102T Advanced Pharmacology-I 4 4 4 100
MPL103T Pharmacological and Toxicological
Screening Methods – I 4 4 4 100
MPL104T Cellular and Molecular Pharmacology 4 4 4 100
MPL105P Pharmacology Practical I 12 6 12 150
Total 35 26 35 650
Semester II
MPL201T Advanced Pharmacology-II 4 4 4 100
MPL202T Pharmacological and Toxicological
Screening Methods – II 4 4 4 100
MPL203T Principles of Drug Discovery 4 4 4 100
MPL204T Clinical Research and Pharmacovigilance 4 4 4 100
MPL205P Pharmacology Practical II 12 6 12 150
Total 35 26 35 650
15
Table 8: Course of Study for M.Pharm III Semester (Common for all
Specializations)
Course Code Course Credit Credit
Hours Points
MRM 301T Research Methodology and Biostatistics* 4 4
- Journal Club 1 1
- Discussion / Presentation (proposal Presentation) 2 2
- Research Work 28 14
Total 35 21
*Non University Examination
Table 9: Course of Study for M.Pharm IV Semester (Common for all

Specializations)
Course Code Course Credit Credit
Hours Points
- Journal Club 1 1
- Research Work 31 16
- Discussion / Final Presentation 3 3
Total 35 20
- Co-curricular and extra-curricular activities 5 5
Grand total 40 25
Table 10: Semester Wise Credit Distribution

Semester Credit Points
I 26
II 26
III 21
IV 20
Co-curricular and extra-curricular activities 5
Grand total 98
16
Table 11: Guidelines for awarding credit points for co-curricular and extra
curricular activities
Sl.No. Name of the Activity Marks Evidence
1. Participation in National Level seminar/ 10 Participation
Conference/ Workshop / Symposium /Training certificate issued by
Programs (related to the specialization of the student) the organizers
2. Participation in international Level Seminar/ 20 Participation
Conference /Workshop /Symposium /Training certificate issued by
Programs (related to the specialization of the student) the organizers
3. Academic Award /Research Award from State 10 Award certificate

Level /National Agencies
4. Academic Award /Research Award from International 20 Award certificate
Agencies
5. Research / Review Publication as first author in 20 Publication re print
National /international Journals (Indexed in Scopus /
Web of Science)
6. Research / Review papers as first author 10 Proof of
communicated to national /International Journals communication
(Indexed in Scopus / Web of Science)
7. Active involvement in organizing seminars /guest 05/event Certification by
lectures etc. of the department event coordinator &
guide
8. Contribution to institutional publication such as 05/contribution Proof of
NGSM Herald, Pharmacy practice communicator contribution
9. Active participation in sports 05 Certification by
Physical director
and Guide
10. Participation in annual day, cultural day, national 2 marks/ event Certification by
festivals such as independence day, republic day etc. event coordinator &
guide
11. Participation in NSS activities of the college 02 marks/ Certification by
program NSS coordinator &
guide
12. Participation in the campus placement 05/participation Certification by
activities/interviews Placement officer
&guide
17
13. Involvement in guiding the junior students by 05 Certification by the

delivering special talks to UG and diploma students guide with proof
14. General skills, attitude and contribution to the vision 05 Certification by
and mission of the college Guide
15. Industrial visit/tour 05 Report on the
industrial visit
16. Any other significant curricular / extra-curricular 05 Certification by the
activity as certified by Heads of the department HoDs
The credit points assigned for extra-curricular and co-curricular activities shall be
earned by the students on the basis of their performance in defined activities. The
assessment of the extra-curricular and co-curricular attainment shall be made by the
activity coordinators, guides and the heads of the departments. The marks obtained
by the students shall be sent to the University by the Head of the Institution.
However, the maximum marks for these activities shall not exceed 50. The marks
obtained by the students shall be converted into letter grades and grade points as
indicated in Table 22, which shall be taken into account while calculating CGPA.
The criteria to acquire this credit point shall be defined by the college from time to
time.
Note: International Conference: Held outside India

International Journal: The Editorial Board outside India
15 Program Committee:
1. The M.Pharm. programme shall have a Programme Committee constituted
by the Head of the institution in consultation with all the Heads of the
departments.
2. The composition of the Programme Committee shall be as follows:
A teacher at the cadre of Professor shall be the Chairperson; One Teacher
from each M.Pharm specialization and four student representatives (two
from each academic year), nominated by the Head of the institution.
3. Duties of the Programme Committee:
i. Periodically reviewing the progress of the classes.
ii. Discussing the problems concerning curriculum, syllabus and the
conduct of classes.
iii. Discussing with the course teachers on the nature and scope of
assessment for the course and the same shall be announced to the
18
students at the beginning of respective semesters.

iv. Communicating its recommendation to the Head of the institution on
academic matters.
v. The Programme Committee shall meet at least twice in a semester
preferably at the end of each sessional exam and before the end
semester exam.
16 Examinations / Assessments:
The schemes for internal assessment and end semester examinations are given
in Table 12-18
16.1 End Semester Examinations
The End Semester Examinations for each theory and practical course
through semesters I to IV shall be conducted by the university except for
the subject with asterisk symbol (*) in table 8 for which examinations
shall be conducted by the subject experts at college level and the
marks/grades shall be submitted to the university.
Table 12: Schemes for internal assessments and end semester examinations
(Pharmaceutics – MPH)
Course Course Internal Assessment End Semester Total
Code Exams Marks
Continuous Sessional Exams Total Marks Duration
Mode Marks Duration
Semester I
MPH101T Modern Pharmaceutical 10 15 1 Hr 25 75 3 Hrs 100
Analytical Techniques
MPH102T Drug Delivery System 10 15 1 Hr 25 75 3 Hrs 100
MPH103T Modern Pharmaceutics 10 15 1 Hr 25 75 3 Hrs 100
MPH104T Regulatory Affairs 10 15 1 Hr 25 75 3 Hrs 100
MPH105P Pharmaceutics Practical I 20 30 6 Hrs 50 100 6 Hrs 150
Seminar/Assignment - - - - - - 100
Total 650
Semester II
MPH201T Molecular Pharmaceutics 10 15 1 Hr 25 75 3 Hrs 100
(Nano Tech and Targeted
DDS)
19
MPH202T Advanced 10 15 1 Hr 25 75 3 Hrs 100

Biopharmaceutics &
Pharmacokinetics
MPH203T Computer Aided Drug 10 15 1 Hr 25 75 3 Hrs 100
Development
MPH204T Cosmetic and 10 15 1 Hr 25 75 3 Hrs 100
Cosmeceuticals
MPH205P Pharmaceutics Practical II 20 30 6 Hrs 50 100 6 Hrs 150
Total 650
(Pharmaceutical Chemistry - MPC)
Code Exams Marks
Mode Marks Duration
Semester I
MPC101T Modern 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical
Analytical
Techniques
MPC1012T Advanced Organic 10 15 1 Hr 25 75 3 Hrs 100
Chemistry -I
MPC103T Advanced Medicinal 10 15 1 Hr 25 75 3 Hrs 100
chemistry
MPC104T Chemistry of 10 15 1 Hr 25 75 3 Hrs 100
Natural Products
MPC105P Pharmaceutical 20 30 6 Hrs 50 100 6 Hrs 150
Chemistry Practical I
Total 650
Semester II
MPC201T Advanced Spectral 10 15 1 Hr 25 75 3 Hrs 100
Analysis
MPC202T Advanced Organic 10 15 1 Hr 25 75 3 Hrs 100
Chemistry -II
20
MPC203T Computer Aided 10 15 1 Hr 25 75 3 Hrs 100

Drug Design
MPC204T Pharmaceutical 10 15 1 Hr 25 75 3 Hrs 100
Process Chemistry
MPC205P Pharmaceutical 20 30 6 Hrs 50 100 6 Hrs 150
Chemistry Practical II
Seminar/Assignment - - - - - 100
Total 650
(Pharmaceutical Quality Assurance - MQA)
Code Exams Marks
Mode Marks Duration
Semester I
MQA101T Modern 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical
Analytical
Techniques
MQA102T Quality Management 10 15 1 Hr 25 75 3 Hrs 100
System
MQA103T Quality Control and 10 15 1 Hr 25 75 3 Hrs 100
Quality Assurance
MQA104T Product Development 10 15 1 Hr 25 75 3 Hrs 100
and Technology
Transfer
MQA105P Pharmaceutical 20 30 6 Hrs 50 100 6 Hrs 150
Quality Assurance
Practical I
Total 650
Semester II
MQA201T Hazards and Safety 10 15 1 Hr 25 75 3 Hrs 100
Management
MQA202T Pharmaceutical 10 15 1 Hr 25 75 3 Hrs 100
Validation
21
MQA203T Audits and 10 15 1 Hr 25 75 3 Hrs 100

Regulatory
Compliance
MQA204T Pharmaceutical 10 15 1 Hr 25 75 3 Hrs 100
Manufacturing
Technology
MQA205P Pharmaceutical 20 30 6 Hrs 50 100 6 Hrs 150
Quality Assurance
Practical II
Total 650
(Pharmaceutical Regulatory Affairs - MRA)
Code Exams Marks
Mode Marks Duration
Semester I
MRA101T Good Regulatory 10 15 1 Hr 25 75 3 Hrs 100
Practices
MRA102T Documentation and 10 15 1 Hr 25 75 3 Hrs 100
Regulatory Writing
MRA103T Clinical Research 10 15 1 Hr 25 75 3 Hrs 100
Regulations
MRA104T Drugs Regulations 10 15 1 Hr 25 75 3 Hrs 100
and other
Legislation in India
and Intellectual
Property Rights
MRA105P Regulatory Affairs 20 30 6 Hrs 50 100 6 Hrs 150
Practical I
Seminar - - - - - - 100
/Assignment
Total 650
22
Semester II
MRA201T Regulatory Aspects 10 15 1 Hr 25 75 3 Hrs 100
of Drugs &
Cosmetics
of Herbal &
Biologicals
of Medical Devices
of Food &
Nutraceuticals
MRA205P Regulatory Affairs 20 30 6 Hrs 50 100 6 Hrs 150
Practical II
Seminar - - - - - - 100
/Assignment
Total 650
(Pharmacy Practice - MPP)
Course Code Course Internal Assessment End Semester Total
Exams Marks
Mode Marks Duration
Semester I
MPP101T Clinical Pharmacy 10 15 1 Hr 25 75 3 Hrs 100
Practice
MPP102T Pharmacotherapeutics-I 10 15 1 Hr 25 75 3 Hrs 100
MPP103T Hospital & Community 10 15 1 Hr 25 75 3 Hrs 100
Pharmacy
MPP104T Clinical Research 10 15 1 Hr 25 75 3 Hrs 100
MPP105P Pharmacy Practice 20 30 6 Hrs 50 100 6 Hrs 150
Practical I
Total 650
23
Semester II
MPP201T Principles of Quality 10 15 1 Hr 25 75 3 Hrs 100
Use of Medicines
MPP202T Pharmacotherapeutics II 10 15 1 Hr 25 75 3 Hrs 100
MPP203T Clinical 10 15 1 Hr 25 75 3 Hrs 100
Pharmacokinetics and
Therapeutic Drug
Monitoring
MPP204T Pharmacoepidemiology 10 15 1 Hr 25 75 3 Hrs 100
& Pharmacoeconomics
MPP205P Pharmacy Practice 20 30 6 Hrs 50 100 6 Hrs 150
Practical II
Total 650
(Pharmacology - MPL)
Exams Marks
Mode Marks Duration
Semester I
MPL101T Modern 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical
Analytical Techniques
MPL102T Advanced 10 15 1 Hr 25 75 3 Hrs 100
Pharmacology-I
MPL103T Pharmacological and 10 15 1 Hr 25 75 3 Hrs 100
Toxicological
Screening Methods - I
MPL104T Cellular and Molecular 10 15 1 Hr 25 75 3 Hrs 100
Pharmacology
MPL105P Pharmacology 20 30 6 Hrs 50 100 6 Hrs 150
Practical I
Seminar /Assignment - - - - - - 100
Total 650
Semester II
MPL201T Advanced 10 15 1 Hr 25 75 3 Hrs 100
Pharmacology-II
24
MPL202T Pharmacological and 10 15 1 Hr 25 75 3 Hrs 100

Toxicological
Screening Methods –
II
MPL203T Principles of Drug 10 15 1 Hr 25 75 3 Hrs 100
Discovery
MPL204T Clinical Research and 10 15 1 Hr 25 75 3 Hrs 100
Pharmacovigilance
MPL205P Pharmacology 20 30 6 Hrs 50 100 6 Hrs 150
Practical II
Total 650
(Semester III & IV)
Exams Marks
Mode Marks Duration
Semester III
MRM 301T Research 10 15 1 Hr 25 75 3 Hrs 100
Methodology and
Biostatistics*
- Journal Club - - - 25 - - 25
- Discussion / - - - 50 - - 50
Presentation
(proposal
Presentation)
- Research Work* - - - - 350 1 Hr 350
Total 525
Semester IV
- Journal Club 25 - - 25
- Discussion / Final 75 - - 75
Presentation
- Research Work and - 400 1 Hr 400
Colloquium
Total 500
*Non University Examination
16.2 Internal Assessment: Continuous Mode

The marks allocated for Continuous mode of Internal Assessment shall
be awarded as per the scheme given below:
25
Table 19: Scheme for awarding internal assessment: Continuous Mode

Theory
Attendance (Refer Table – 20) 8
Student – Teacher interaction 2
Total 10
Practical
Attendance (Refer Table – 20) 10
Based on Practical Records, Regular viva voce, etc. 10
Total 20
Table 20: Guidelines for the allotment of marks for attendance

Percentage of Attendance Theory Practical
95–100 8 10
90-94 6 7.5
85-89 4 5.0
80-84 2 2.5
Less than 80 0 0
16.2.1 Sessional Exams

Minimum two sessional exams shall be conducted for each theory
/ practical course as per the schedule fixed by the college(s). The
scheme of question paper for theory and practical sessional
examinations is given in the table. The average marks of two
sessional exams shall be computed for internal assessment as per
the requirements given in tables.
Question paper pattern for sessional theory examinations
1. Long Answers (Answer 1 out of 2) - 1 x 10 = 10
2. Short Answers (Answer 4 out of 5) - 4 x 5 = 20
=========
Total = 30 Marks
=========
Question paper pattern for sessional Practical examinations
1. Synopsis - 10
2. Experiment – I (Core Subject) - 25
26
3. Experiment – II (MPAT) - 15
4. Viva voce - 10
==========
Total = 60 Marks
==========
Question Paper pattern - Modern Pharmaceutical Analytical Techniques (MPAT)
Sessional Practical examinations
Core subject MPAT Total
Synopsis 07 03 10
Experiment-I 25 - 25
Experiment-II - 15 15
Viva-voce 08 02 10
Total 40 20 60
Scheme for awarding internal assessment in continuous mode

Attendance 07 03 10
Practical records and 07 03 10
viva voce
Total 14 06 20
17. Promotion and award of grades:

A candidate shall be declared as pass if he secures 50% of marks (including
internal assessment) in each subject in theory and practical examination
separately in each semester provided he secures a minimum of 40% marks in
the university theory and practical examination separately.
Theory and practical subjects are considered as independent subjects. The

candidate who fails either in theory or practical subject has to appear only in
theory or practical as the case may be in the subsequent examinations.
18. Carry forward of marks:

In case a student fails to secure the minimum 50% in any Theory or Practical
course as specified in 12, then he/she shall reappear for the end semester
examination of that course. However his/her marks of the Internal Assessment
shall be carried over and he/she shall be entitled for grade obtained by him/her
on passing.
27
19. Improvement of internal assessment:

A student shall have the opportunity to improve his/her performance only once
in the sessional exam component of the internal assessment. The re-conduct of
the sessional exam shall be completed before the commencement of next end
semester theory examinations.
20. Re-examination of end semester examinations:

Re-examination of end semester examination shall be conducted as per the
schedule given in table 21. The exact dates of examinations shall be notified
from time to time.
Table – 21: Tentative schedule of end semester examinations

Semester For Regular Candidates For Failed Candidates
I and III November / December May / June
II and IV May / June November / December
Question paper pattern for end semester theory examinations

1. Long Answers (Answer 3 out of 4) - 3 x 10 = 30
2. Short Answers (Answer 9 out of 11) - 9 x 5 = 45
--------------------
Total =75 Marks
Question paper pattern for end semester Practical examinations

1. Synopsis - 15
2. Experiment – I - 40
3. Experiment – II - 30
4. Viva voce - 15
--------------------
Total = 100 Marks
Question Paper pattern for end semester Practical examinations -

Modern Pharmaceutical Analytical Techniques (MPAT)
Synopsis 10 05 15
Experiment 1 30 10 40
Experiment 2 20 10 30
Viva-voce 10 5 15
Total 70 30 100
28
21. Allowed To Keep Terms (ATKT):

No student shall be admitted to any examination unless he/she fulfills the
norms given in 11. ATKT rules are applicable as follows:
A student shall be eligible to carry forward all the courses of I and II semesters
till the III semester examinations. However, he/she shall not be eligible to
attend the courses of IV semester until all the courses of I, II and III semesters
are successfully completed.
A student shall be eligible to get his/her CGPA upon successful completion
of the courses of I to IV semesters within the stipulated time period as per the
norms.
Note: Grade AB should be considered as failed and treated as one head for deciding
ATKT. Such rules are also applicable for those students who fail to register for
examination(s) of any course in any semester.
22. Grading of performances

Letter grades and grade points allocations: Based on the performances,
each student shall be awarded a final letter grade at the end of the semester for
each course. The letter grades and their corresponding grade points are given
in Table – 22.
Table – 22: Letter grades and grade points equivalent to Percentage of marks
and performances
Marks Range Grade Point Letter Grade Description
(%)
90 & Above 10 O Outstanding First Class with
80-89.9 09 A Excellent Distinction
75-79.9 08 B Very Good
60-74.9 07 C Good First Class
55-59.9 06 D Fair Second Class
50-54.9 05 E Average Pass
Less than 50 0 F Fail Fail
Absent 0 AB Fail Fail
A student who remains absent for any semester end examination shall be
assigned a letter grade of AB and a corresponding grade point of zero.
He/she should reappear for the said evaluation/examination in due course.
29
23. The Semester grade point average (SGPA):

The performance of a student in a semester is indicated by a number called
‘Semester Grade Point Average’ (SGPA). The SGPA is the weighted average
of the grade points obtained in all the courses by the student during the semester.
For example, if a student takes five courses (Theory/Practical) in a semester
with credits C1, C2, C3 and C4 and the student’s grade points in these courses
are G1, G2, G3 and G4, respectively, and then students’ SGPA is equal to:
SGPA = C1G1 + C2G2 + C3G3 + C4G4

-----------------------------------------------
C1 + C2 + C3 + C4
The SGPA is calculated to two decimal points. It should be noted that, the SGPA
for any semester shall take into consideration the F and ABS grade awarded in
that semester. For example if a learner has a F or ABS grade in course 4,
theSGPA shall then be computed as:
SGPA = C1G1 + C2G2 + C3G3 + C4* ZERO

-----------------------------------------------
C1 + C2 + C3 + C4
24. Cumulative Grade Point Average (CGPA):

The CGPA is calculated with the SGPA of all the IV semesters to two decimal
points and is indicated in final grade report card/final transcript showing the
grades of all IV semesters and their courses. The CGPA shall reflect the failed
status in case of F grade(s), till the course(s) is/are passed. When the course(s)
is/are passed by obtaining a pass grade on subsequent examination(s) the CGPA
shall only reflect the new grade and not the fail grades earned earlier. The CGPA
is calculated as:
CGPA = C1S1 + C2S2 + C3S3 + C4S4
-------------------------------------------------
C1 + C2 + C3 + C4
where C1, C2, C3,…. is the total number of credits for semester I,II,III,…. and
S1,S2, S3,….is the SGPA of semester I,II,III,…. .
30
25. Declaration of Results and Classification:

The class shall be awarded to those who pass the examination in first attempt
on the sbasis of CGPA as follows:
First Class with Distinction : CGPA 7.50 and above
First Class : CGPA 6.00 to 7.49
Second Class : CGPA 5.00 to 5.99
Candidates who pass the examination in more than one attempt shall be
declared as passed in “pass” class irrespective of the percentage of marks
secured.
An attempt means the appearance of a candidate for one or more courses either
in part or full in a particular examination.
A candidate who fails in main examination and passes one or more subjects
or all subjects in the supplementary examination is not eligible for award of
class or distinction. Passing in supplementary examination by such candidates
shall be considered as attempt.
If a candidate submits application for appearing for the regular examination
but does not appear for any of the courses/subjects in the regular University
examination, he can appear for supplementary examination provided other
conditions such as attendance requirement, internal assessment marks, etc. are
fulfilled and his appearing in the supplementary examination shall be
considered as the first attempt.
Candidates who pass the subjects in the supplementary examinations are not
eligible for the award of Gold Medal or Merit Certificate.
26. Project work (Dissertation):

All the students shall undertake a project under the supervision of a teacher in
Semester III to IV and submit a report. 4 copies of the project report shall be
submitted (typed & bound copy not less than 75 pages).
The internal and external examiner appointed by the University shall evaluate
the project at the time of the Practical examinations of other semester(s). The
projects shall be evaluated as per the criteria given below.
Evaluation of Dissertation Book:
Objective(s) of the work done 25 Marks
Methodology adopted 75 Marks
Results and Discussions 100 Marks
Conclusions and Outcomes 50 Marks
Total 250 Marks
31
Evaluation of Presentation:
Presentation of work 75 Marks
Communication skills 50 Marks
Question and answer skills 25 Marks
Total 150 Marks
The minimum Marks for Pass in the dissertation is 50% of marks of the aggregate
marks for University Evaluation.
27. Dissertation
As a partial requirement of the course, a candidate is required to carry out a
study in a select area of his specialty, under the supervision of a faculty Guide.
The results of such a study shall be submitted to the University in the form of a
dissertation as per the prescribed format and within the date stipulated by the
University. Only a candidate who has put in a minimum of 80% attendance in
the second year be eligible to submit the dissertation. The dissertation is aimed
at training a postgraduate candidate in research methodology and techniques. It
includes identification of the problem, formulation of a hypothesis, review of
literature, getting acquainted with recent advances, designing of a research
study, collection of data, critical analysis and comparison of results and drawing
conclusions.
27.1 Schedule
Submission of the synopsis to Within one month of the commencement of II semester
the University
Ethical clearance Fifteen days before the end of second semester
Final submission of the 1 month before the IV semester University examination or
dissertation as per dates specified by the University
27.2 Guide
A guide shall be a full time post graduate teacher of the Institution and
recognized by the University as a Guide for supervision of dissertation
work. However, a co- guide can be opted wherever required with prior
permission of the Institution and University. The co-guide shall also be a
postgraduate teacher recognized by the University as Guide. In the event
of registered guide leaving the Institution or in the event of death of the
32
guide, a change of guide shall be permitted by the University, on the

specific recommendation of the Institution.
27.3 Ethical Clearance:

Ethical clearance should be obtained for a study involving any procedure
on human subject. A candidate should apply for the certificate to the
Ethics Committee of the Institute, through the Guide and present the
study before the Committee for clearance. A copy of the certificate
should be attached along with the synopsis forwarded at the time of
approval of synopsis. All such clearance should be sought within six
months of the commencement of the course.
27.4 Submission of Synopsis
A candidate shall submit a synopsis to the University through the Guide
and Head of the Institution, not later than nine months from the
commencement of the I year OR within the date notified by the
University, whichever is earlier. Once the synopsis is approved and
registered by the University no change in the topic or Guide shall be made
without the prior approval of the University.
27.5 Preparation of Dissertation:
a. The dissertation should be written under the following headings
and order:
i. Introduction
ii. Aims or Objectives of the study
iii. Review of literature
iv. Material and methods
v. Results
vi. Discussion
vii. Summary and Conclusions
viii. References
ix. Tables
x. Annexure
b. The written text of dissertation shall be not less than 75 pages and
shall not exceed 200 pages excluding references, tables,
questionnaires and other annexure. It should be neatly typed with
double line spacing on one side of the bond paper (A4 size, 8.27” x
11.69”) and bound properly. Spiral binding should be avoided.
33
27.6 Submission of Dissertation:

The final dissertation in the prescribed format and certified by the Guide
and co-guide if any, Head of the Department and Head of the Institution
should be submitted to the University one month before the final
examination or as notified by the University.
27.7 Viva-Voce Examination:
The Viva-Voce examination shall aim at assessing the depth of
knowledge, logical reasoning, confidence and oral communication skills.
The Viva-Voce examination shall be held after the submission of

dissertation. If any candidate fails to submit the dissertation on or before
the date prescribed, his Viva-Voce shall be conducted during the
subsequent examination.
28 Graduation Requirements:
A candidate shall be declared eligible for the award of the degree if he has:
• Fulfilled Degree Requirement
• No dues to the University, Institute, Departments, Hostels, Library etc.
• No disciplinary action pending against him.
The award of the degree must be recommended by the Board of Management.
29 Award of Ranks:
Ranks and Medals shall be awarded on the basis of final CGPA. However,
candidates who fail in one or more courses during the M.Pharm program shall
not be eligible for award of ranks. Moreover, the candidates should have
completed the M. Pharm program in minimum prescribed number of years, (two
years) for the award of Ranks.
30 Award of degree:
Candidates who fulfill the requirements mentioned above shall be eligible for
award of degree during the ensuing convocation.
31 Revaluation / Re-totaling of answer papers:

There is no provision for revaluation of the answer papers in any examination.
The candidates can apply for retotaling/photocopy of the answer scripts by
34
paying prescribed fee.
32 Re-admission after break of study:

Candidate who seeks re-admission to the program after break of study has to
get the approval from the university by paying a condonation fee.
33 Convocation:
Degrees will be awarded in person for the candidates who have graduated
during the preceding academic year. Degrees will be awarded in absentia to
such candidates who are unable to attend the convocation. Candidates are
required to apply for the convocation along with prescribed fee within the
specified date, after having satisfactorily completed all degree requirements of
the course.
Provisional pass certificate will be issued by the University provided the

candidate fulfills requirements mentioned in clause (11) above. The provisional
certificate will be issued on submission of an application through the college
and will be valid until the convocation.
35
GUIDELINES FOR PHARMACY STUDENTS FOR CARRYING

OUT INDUSTRIAL PROJECTS IN PARTIAL FULFILLMENT OF
M.PHARM DEGREE
Preamble:
In an attempt to increase industry-academic collaboration, it was proposed to permit
certain percentage of M.Pharm students to pursue the research work leading to the
dissertation work of II year M.Pharm course at pharmaceutical industry/research
laboratories of public or private section. The long term benefits of such initiatives
are:
1. Possible better placement opportunities
2. Exposure to industrial environment while being a student
3. Institution-industry collaboration may result in funded projects from the
industry
4. Relevance of curriculum up gradation.
In the past, some colleges have practiced this.
Care to be taken by the sponsoring institution to see that students pursue the projects
seriously, serious monitoring of the work being done and work taken up is of high
standard.
Guidelines:
1. The candidates desire of doing the projects in industry, after preliminary home
work of selection of industry, co guide and project title, shall apply to the
principal at least one month prior to the start of II Sem. M.Pharm University
Examinations.
2. The Principal along with the Committee appointed for the purpose of
scrutinizing the applications shall select and approve the projects with the
following conditions:
i. Not more than 30% of students from each branch will be permitted.
ii. Not more than one student from the institutional guide will be permitted
iii. The industry/research lab should be approved by the
College/University. (The candidate has to supply the particulars
regarding the organization and co-guide).
iv. The name of the co-guide should be approved by the University BOS
in the faculty.
36
v. The candidates will be selected on the basis of merit (B.Pharm marks

and M.Pharm internal assessment marks)
vi. Only those students who have put minimum of 80% attendance and
have passed all the subjects in I year M.Pharm will be eligible.
3. The candidates shall submit the project protocol along with the application to
the college duly endorsed by the guide and co-guide.
4. The student shall do the project work at the selected centre for a minimum of
180 days and maximum of 220 days
5. Letter of consent from the co-guide and No Objection from the Project Centre
Headshould be produced along with the application.
6. The first, second and third presentation of the Protocol by the student will be at
the institution.
Minimum qualification for Co- guideship for M.Pharm.

• Industrial Pharmacy: M. Pharm or Ph.D. with 3 years of experience in
manufacturing or in R & D / Quality Control in a reputed pharmaceutical
industry.
• Pharmacy Practice: A recognized PG teacher of Nitte (Deemed to be
University) belonging to any faculty of health sciences from any affiliated
colleges having approved post graduate courses.
• A co-guide can guide a maximum of two students at a time.
*********
37
PHARMACEUTICS (MPH)
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPH 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for
identification, characterization and quantification of drugs. Instruments dealt are
NMR, Mass spectrometer, IR, HPLC, GC etc.
Course Outcome
At the end of the course students will be able to...
CO1 Explain general principles and theory of spectroscopy
CO2 Understand the basic instrumentation of HPTLC, HPLC, GC for
identification, and characterization of compounds
CO3 Understand the basic concept and instrumentation of
Chromatographic techniques
CO4 Learn various separation techniques by employing chromatographic
methods
CO5 Understand the basic principles and instrumentation of fluorimeter
and atomic absorption spectrometer
CO6 Learn general principles and instrumentation of ion selective
electrodes.
CO7 Identify organic compounds by –X-ray crystallography
CO8 Explain Instrumentation, separation and identification of compounds
by electrophoresis technique.
Units Contents Hours

1 a. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 10
associated with UV-Visible spectroscopy, Choice of solvents and
solvent effect and Applications of UV-Visible spectroscopy, Difference/
Derivative spectroscopy.
b. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample
handling, Instrumentation of Dispersive and Fourier - Transform IR
Spectrometer, Factors affecting vibrational frequencies and
Applications of IR spectroscopy, Data Interpretation.
38
c. Spectroflourimetry: Theory of Fluorescence, Factors affecting

fluorescence (Characterestics of drugs that can be analysed by
flourimetry), Quenchers, Instrumentation and Applications of
fluorescence spectrophotometer.
d. Flame emission spectroscopy and Atomic absorption spectroscopy:
Principle, Instrumentation, Interferences and Applications.
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 10
Instrumentation, Solvent requirement in NMR, Relaxation process, NMR
signals in various compounds, Chemical shift, Factors influencing chemical
shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double
resonance, Brief outline of principles of FT-NMR and 13C NMR.
Applications of NMR spectroscopy.
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass 10
Spectroscopy, Different types of ionization like electron impact, chemical,
field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and
Time of Flight, Mass fragmentation and its rules, Meta stable ions,
Isotopic peaks and Applications of Mass spectroscopy.
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 10
parameters, factors affecting resolution, isolation of drug from excipients,
data interpretation and applications of the following:
a. Thin Layer chromatography
b. High Performance Thin Layer Chromatography
c. Ion exchange chromatography
d. Column chromatography
e. Gas chromatography
f. High Performance Liquid chromatography
g. Ultra High Performance Liquid chromatography
h. Affinity chromatography
i. Gel Chromatography
5 a. Electrophoresis: Principle, Instrumentation, Working conditions, 10
factors affecting separation and applications of the Hrs following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary
electrophoresis d) Zone electrophoresis e) Moving boundary
electrophoresis f) Iso electric focusing
b. X ray Crystallography: Production of X rays, Different X ray methods,
Bragg‘s law, Rotating crystal technique, X ray powder technique, Types
of crystals and applications of X-ray diffraction.
39
6 a. Potentiometry: Principle, working, Ion selective Electrodes and 10

Application of potentiometry.
b. Thermal Techniques: Principle, thermal transitions and
Instrumentation (Heat flux and power-compensation and designs),
Modulated DSC, Hyper DSC, experimental parameters (sample
preparation, experimental conditions, calibration, heating and cooling
rates, resolution, source of errors) and their influence, advantage and
disadvantages, pharmaceutical applications. Differential Thermal
Analysis (DTA): Principle, instrumentation and advantage and
disadvantages, pharmaceutical applications, derivative differential
thermal analysis (DDTA). TGA: Principle, instrumentation, factors
affecting results, advantage and disadvantages, pharmaceutical
applications.
c. Immunological assays: RIA (Radio immuno assay), ELISA,
Bioluminescence assays.
References
1. Spectrometric Identification of Organic compounds - Robert M Silverstein,
Sixth edition, John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,
Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition,
CBS Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd
Edition, CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11,
Marcel. Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern Ltd.,
Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley &
Sons, 1982.
40
DRUG DELIVERY SYSTEMS (MPH 102T)
Scope
This course is designed to impart knowledge on the area of advances in novel drug
delivery systems.
Course Outcome
CO1 Select drugs as suitable candidates for various novel drug delivery
systems based on their physic-chemical properties
CO2 Select polymers, retardants and other additives based on the
requirements and desired characteristics of the drug delivery
system
CO3 Formulate and design controlled release and sustained release
drug delivery systems.
CO4 Evaluate drug delivery systems for physic-chemical
characteristics, in vitro and in vivo drug release
CO5 Conduct stability studies for dosage forms as per prescribed
guidelines
CO6 Describe the importance of personalized medicine in the
optimization of therapy in patients
CO7 Develop the concept of Telepharmacy to benefit hospitals and
clinics without direct access to a pharmacist
CO8 Apply knowledge of protein drugs and biological products such
as vaccines in their development and evaluation

1 Sustained Release(SR) and Controlled Release (CR) formulations: 10
Introduction & basic concepts, advantages/ Hrs disadvantages, factors
influencing, Physicochemical & biological approaches for SR/CR formulation,
Mechanism of Drug Delivery from SR/CR formulation. Polymers:
introduction, definition, classification, properties and application Dosage
Forms for Personalized Medicine: Introduction, Definition, Pharmacogenetics,
Categories of Patients for Personalized Medicines: Customized drug delivery
systems, Bioelectronic Medicines, 3D printing of pharmaceuticals,
Telepharmacy.
41
2 Rate Controlled Drug Delivery Systems: Principles & Fundamentals, Types, 10

Activation; Modulated Drug Delivery Systems; Mechanically activated, pH
activated, Enzyme activated, and Osmotic activated Drug Delivery Systems
Feedback regulated Drug Delivery Systems; Principles & Fundamentals.
3 Gastro-Retentive Drug Delivery Systems: Principle, concepts advantages 10

and disadvantages, Modulation of GI transit time approaches to extend GI
transit. Buccal Drug Delivery Systems: Principle of muco adhesion,
advantages and disadvantages, Mechanism of drug permeation, Methods of
formulation and its evaluations.
4 Occular Drug Delivery Systems: Barriers of drug permeation, Methods to 06
overcome barriers.
5 Transdermal Drug Delivery Systems: Structure of skin and barriers, 10
Penetration enhancers, Transdermal Drug Delivery Systems, Formulation and
evaluation.
6 Protein and Peptide Delivery: Barriers for protein delivery. Formulation 08
and Evaluation of delivery systems of proteins and other macromolecules.
7 Vaccine delivery systems: Vaccines, uptake of antigens, single shot 06
vaccines, mucosal and transdermal delivery of vaccines.
References
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and
expanded, Marcel Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel
Dekker,Inc., New York, 1992.
3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by
WileyInterscience Publication, John Wiley and Sons, Inc, New York!
Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers &
Distributors, New Delhi, First edition 1997 (reprint in 2001)
5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002
Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian drugs (IDMA)
3. Journal of controlled release (Elsevier Sciences) desirable
4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable
42
MODERN PHARMACEUTICS (MPH 103T)
Scope
Course designed to impart advanced knowledge and skills required to learn various
aspects and concepts at pharmaceutical industries
Course Outcome
CO1 Understand the concept and importance of preformulation parameters
CO2 Know the compression and consolidation parameters for powders and
granules in tablet development.
CO3 Apply the statistical design in the development of different
formulations.
CO4 Have knowledge of optimization techniques and their applications in
pharmaceutical industries.
CO5 Know the scope and merits of validation and different types of
validation
CO6 Understand the importance of industrial management principles and
GMP Considerations.
CO7 Understand the importance of materials management and production
management in pharmaceutical industries
CO8 Know the ICH and WHO guidelines for calibration and validation of
equipments

1 a. Preformation Concepts– Drug Excipient interactions - different 10
methods, kinetics of stability, Stability testing. Theories of dispersion
and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS)
preparation and stability Large and small volume parental –
physiological and formulation consideration, Manufacturing and
evaluation.
b. Optimization techniques in Pharmaceutical Formulation: Concept
and parameters of optimization, Optimization techniques in 10
pharmaceutical formulation and processing. Statistical design, Response
surface method, Contour designs, Factorial designs and application in
formulation
43
2 Validation : Introduction to Pharmaceutical Validation, Scope & merits of 10

Validation, Validation and calibration of Master plan, ICH & WHO
guidelines for calibration and validation of equipments, Validation of specific
dosage form, Types of validation. Government regulation,
Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
3 cGMP & Industrial Management: Objectives and policies of current good 10
manufacturing practices, layout of buildings, Hrs services, equipments and
their maintenance Production management: Production organization, ,
materials management, handling and transportation, inventory management
and control, production and planning control, Sales forecasting, budget and
cost control, industrial and personal relationship. Concept of Total Quality
Management.
4 Compression and compaction: Physics of tablet compression, 10
compression, consolidation, effect of friction, distribution of forces,
compaction profiles. Solubility.
5 Study of consolidation parameters: Diffusion parameters, Dissolution 10
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors
– f2 and f1, Higuchi and Peppas plot, Linearity Concept of significance,
Standard deviation , Chi square test, students T-test , ANOVA test.
References:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon
Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon
Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H. Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total
quality control, Second edition; By Sidney H. Willig.
11. Quality Assurance Guide; By Organization of Pharmaceutical producers of
India.
44
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern

publishers, New Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans,
Anderson, Sweeney and Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.
45
REGULATORY AFFAIRS (MPH 104T)
Scope
Course designed to impart advanced knowledge and skills required to learn the
concept of generic drug and their development, various regulatory filings in different
countries, different phases of clinical trials and submitting regulatory documents:
filing process of IND, NDA and ANDA
Course Outcome
CO1 Discuss the concept of innovator and generic drugs, drug
development process
CO2 Discuss the regulatory guidance’s and guidelines for filing and
approval process
CO3 Categorize the preparation of dossiers and their submission to
regulatory agencies in different countries
CO4 Assess the post approval requirements for actives and drug
products
CO5 Enumerate the documents required for submission in CTD/eCTD
CO6 Describe the clinical trials requirements for approvals for
conducting clinical trials
CO7 Discuss the concept of non-clinical drug development
CO8 Discuss the role of pharmacovigilance and the process of
monitoring in clinical trials

1 a. Documentation in Pharmaceutical industry: Master formula record, 12
DMF (Drug Master File), distribution records. Generic drugs product
development Introduction , Hatch- Waxman act and amendments, CFR
(CODE OF FEDERAL REGULATION) ,drug product performance, in-
vitro, ANDA regulatory approval process, NDA approval process, BE
and drug product assessment, in –vivo, scale up process approval
changes, post marketing surveillance, outsourcing BA and BE to CRO.
b. Regulatory requirement for product approval: API, biologics, novel,
therapies obtaining NDA, ANDA for generic drugs ways and means of
US registration for foreign drugs
46
2 CMC, post approval regulatory affairs. Regulation for combination products 12

and medical devices.CTD and ECTD format, industry and FDA liaison. ICH
- Guidelines of ICH-Q, S E, M. Regulatory requirements of EU, MHRA,
TGA and ROW countries.
3 Non clinical drug development: Global submission of IND, NDA, ANDA. 12
Investigation of medicinal products dossier, dossier (IMPD) and
investigator brochure (IB).
4 Clinical trials: Developing clinical trial protocols. Institutional review board/ 12
independent ethics committee Formulation and working procedures informed
Consent process and procedures. HIPAA- new, requirement to clinical study
process, pharmacovigilance safety monitoring
in clinical trials.
References
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and IsaderKaufer,Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry
and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185, Informa
Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
& Sons.Inc.
5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited By Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https://www.tga.gov.au/tga-basics
47
PHARMACEUTICS PRACTICALS - I (MPH 105P)
1. Analysis of pharmacopoeial compounds and their formulations by UV Vis

spectrophotometer
2. Simultaneous estimation of multi component containing formulations by
UV spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
7. To perform In-vitro dissolution profile of CR/ SR marketed formulation
8. Formulation and evaluation of sustained release matrix tablets
9. Formulation and evaluation osmotically controlled DDS
10. Preparation and evaluation of Floating DDS- hydro dynamically balanced
DDS
11. Formulation and evaluation of Muco adhesive tablets.
12. Formulation and evaluation of trans dermal patches.
13. To carry out preformulation studies of tablets.
14. To study the effect of compressional force on tablets disintegration time.
15. To study Micromeritic properties of powders and granulation.
16. To study the effect of particle size on dissolution of a tablet.
17. To study the effect of binders on dissolution of a tablet.
18. To plot Heckal plot, Higuchi and peppas plot and determine similarity
factors.
48
MOLECULAR PHARMACEUTICS
(NANO TECHNOLOGY & TARGETED DDS) (NTDS) (MPH 201T)
Scope
This course is designed to impart knowledge on the area of advances in novel drug
delivery systems.
Course Outcome
CO1 Design drug delivery systems for targeting drugs to tumours and to the
brain
CO2 Prepare and evaluate nanoparticles and liposomes as carriers for drug
targeting
CO3 Select drugs and polymers in the design of microspheres and
microcapsules for various applications.
CO4 Formulate aquasomes, niosomes, phytosomes and electrosomes for
various applications in drug targeting
CO5 Develop strategies for improving nasal absorption in the design of nasal
drug delivery systems
CO6 Optimize pulmonary delivery by the design of suitable aerosols,
nebulizers and dry powder inhalers
CO7 Apply knowledge of antisense molecules and aptamers in the design of
novel drug delivery systems
CO8 Apply gene therapy in the treatment of cancer and inherited diseases

1 Targeted Drug Delivery Systems: Concepts, Events and biological 12
process involved in drug targeting. Tumor targeting and Hrs Brain specific
delivery.
2 Targeting Methods: introduction preparation and evaluation. 12
Nano Particles & Liposomes: Types, preparation and evaluation.
3 Micro Capsules / Micro Spheres: Types, preparation and evaluation, 12
Monoclonal Antibodies: preparation and application, Hrs preparation and
application of Niosomes, Aquasomes, Phytosomes, Electrosomes.
4 Pulmonary Drug Delivery Systems: Aerosols, propellents, 12
ContainersTypes, preparation and evaluation, Intra Nasal Route Delivery
systems; Types, preparation and evaluation.
49
5 Nucleic acid based therapeutic delivery system: Gene therapy, 12

introduction (ex-vivo & in-vivo gene therapy). Potential target diseases for
gene therapy (inherited disorder and cancer). Gene expression systems (viral
and nonviral gene transfer). Liposomal gene delivery systems.
Biodistribution and Pharmacokinetics. knowledge of therapeutic antisense
molecules and aptamers as drugs of future.
References
1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and
expanded, Marcel Dekker, Inc., New York, 1992.
2. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances,
VallabhPrakashan, New Delhi, First edition 2002.
3. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers &
Distributors, NewDelhi, First edition 1997 (reprint in 2001).
50
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS

(MPH 202T)
Scope
This course is designed to impart knowledge and skills necessary for dose
calculations, dose adjustments and to apply biopharmaceutics theories in practical
problem solving. Basic theoretical discussions of the principles of biopharmaceutics
and pharmacokinetics are provided to help the students’ to clarify the concepts.
Course Outcome
CO1 Explain mechanism of drug absorption &various factors affecting
drug absorption
CO2 Learn various biopharmaceutic factors affecting drug bioavailability
CO3 Learn various method of dissolution testing. In vitro–in vivo
correlation dissolution data.
CO4 Understand basic considerations of pharmacokinetic models.
Understand different compartment model and non-compartment
model
CO5 Explain the design and evaluation of dosage regimens of the drugs
using pharmacokinetic and `biopharmaceutic parameters.
CO6 Learn different types of drug interactions which alter the
pharmacokinetics of such as drug-protein /drug-tissue binding
interactions
CO7 Elaborate design Bioavailability and Bioequivalence studies of new
drugs or dosage forms
CO8 Study the application of pharmacokinetics and pharmacodynamics of
biotechnology drugs.

1 Drug Absorption from the Gastrointestinal Tract: Gastrointestinal 12
tract, Mechanism of drug absorption, Factors affecting drug absorption,
pH– partition theory of drug absorption. Formulation and
physicochemical factors: Dissolution rate, Dissolution process, Noyes–
Whitney equation and drug dissolution, Factors affecting the
dissolution rate. Gastrointestinal absorption: role of the dosage form:
Solution (elixir, syrup and solution) as a dosage form ,Suspension as a
dosage form, Capsule as a dosage form, Tablet as a dosage form,
Dissolution methods ,Formulation and processing factors
51
Correlation of in vivo data with in vitro dissolution data.Transport model:

Permeability-Solubility-Charge State and the pH Partition Hypothesis,
Properties of the Gastrointestinal Tract (GIT), pH Microclimate
Intracellular pH Environment, Tight-Junction Complex.
2 Biopharmaceutic considerations in drug product design and In Vitro 12
Drug Product Performance: Introduction, biopharmaceutic factors
affecting drug bioavailability, rate-limiting steps in drug absorption,
physicochemical nature of the drug formulation factors affecting drug
product performance, in vitro: dissolution and drug release testing,
compendial methods of dissolution, alternative methods of dissolution
testing,meeting dissolution requirements,problems of variable control in
dissolution testingperformance of drug products. In vitro–in vivo correlation,
dissolution profile comparisons, drug product stability, considerations in the
design of a drug product.
3 Pharmacokinetics: Basic considerations, pharmacokinetic models, 12
compartment modeling: one compartment model- IV bolus, IV infusion,
extra-vascular. Multi compartment model:two compartment - model in brief,
non-linear pharmacokinetics: causeof non-linearity, Michaelis – Menten
equation, estimation of kmax and vmax. Drug interactions: introduction, the
effect of protein-binding interactions, the effect of tissue- binding
interactions,cytochrome p450-based drug interactions, drug interactions
linked to transporters.
4 Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: 12
drug product performance, purpose of bioavailability studies, relative and
absolute availability. Methods for assessing bioavailability, bioequivalence
studies, design and evaluation of bioequivalence studies, study designs,
crossover study designs, evaluation of the data, bioequivalence example,
study submission and drug review process. biopharmaceutics classification
system, methods. Permeability: In- vitro, in-situ and In-vivo methods.generic
biologics (biosimilar drug products), clinical significance of bioequivalence
studies, special concerns in bioavailability and bioequivalence studies,
generic substitution.
52
5 Application of Pharmacokinetics: Modified-Release Drug Products, 12

Targeted Drug Delivery Systems and Biotechnological Products.
Introduction to Pharmacokinetics and pharmacodynamic, drug interactions.
Pharmacokinetics and pharmacodynamics of biotechnology drugs.
Introduction, Proteins and peptides, Monoclonal antibodies,
Oligonucleotides, Vaccines (immunotherapy), Gene therapies.
References
1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,
Philadelphia, Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and
Sunil B. Jaiswal., VallabPrakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC,
2ndedition, Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R.
Hiremath, Prism Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker
Inc.,New York, 1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J,
Leaand Febiger, Philadelphia, 1970
7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm
Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack
Publishing Company, Pennsylvania 1989
9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition,
revised and expanded by Robert. E. Notari, Marcel Dekker Inc, New York and
Basel,1987.
10. Biopharmaceutics and Relevant Pharmacokinetics by John. G
Wagner and M. Pemarowski, 1st edition, Drug Intelligence Publications,
Hamilton, Illinois, 1971.
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James.
G. Boylan, Marcel Dekker Inc, New York, 1996.
12. Basic Pharmacokinetics,1 st edition, Sunil S Jambhekar and Philip J Breen,
pharmaceutical press, RPS Publishing,2009.
13. Absorption and Drug Development- Solubility, Permeability, and Charge State,
Alex Avdeef, John Wiley & Sons, Inc,2003.
53
COMPUTER AIDED DRUG DEVELOPMENT (MPH 203T)
Scope
This course is designed to impart knowledge and skills necessary for computer
Applications in pharmaceutical research and development who want to understand
the application of computers across the entire drug research and development
process. Basic theoretical discussions of the principles of more integrated and
coherent use of computerized information (informatics) in the drug development
process are provided to help the students to clarify the concepts.
Course Outcome
CO1 Understand the applications of computers in pharmaceutical product
development
CO2 Learn statistical modeling principles & optimization using computer
applications
CO3 Understand the basics of Quality by design in formulation
development
CO4 Know the basic computational modeling principles for drug
disposition
CO5 Learn computer aided biopharmaceutical characterization of drugs
CO6 Learn computer simulation in pharmacokinetics and
pharmacodynamics
CO7 Study the use of computers in clinical development of drugs
CO8 Undertand the need of industrial automation by application of
artificial intellingence, robotics and computational fluid dynamics

1 a. Computers in Pharmaceutical Research and Development: A 12
General Overview: History of Computers in Hrs Pharmaceutical
Research and Development. Statistical modelingin Pharmaceutical
research and development: Descriptive versus Mechanistic Modeling,
Statistical Parameters, Estimation, Confidence Regions, Nonlinearity at
the Optimum, Sensitivity Analysis, Optimal Design, Population
Modeling
54
b. Quality-by-Design in Pharmaceutical Development: Introduction,

ICH Q8 guideline, Regulatory and industry views on QbD,
Scientifically based QbD - examples of application.
2 Computational Modeling Of Drug Disposition: Introduction, Modeling 12
Techniques: Drug Absorption, Solubility, Intestinal Permeation, Drug
Distribution ,Drug Excretion, Active Transport; P-gp, BCRP, Nucleoside
Transporters, hPEPT1, ASBT, OCT, OATP, BBB-Choline Transporter.
3 Computer-aided formulation development: Concept of optimization, 12
Optimization parameters, Factorial design, Optimization technology &
Screening design. Computers in Pharmaceutical Formulation: Development
of pharmaceutical emulsions, microemulsion drug carriers Legal Protection
of Innovative Uses of Computers in R&D, The Ethics of Computing in
Pharmaceutical Research, Computers in Market analysis
4 a. Computer-aided biopharmaceutical characterization: 12
Gastrointestinal absorption simulation. Introduction, Theoretical
background, Model construction, Parameter sensitivity analysis, Virtual
trial, Fed vs. fasted state, In vitro dissolution and in vitro- in vivo
correlation, Biowaiver considerations
b. Computer Simulations in Pharmacokinetics and
Pharmacodynamics: Introduction, Computer Simulation: Whole
Organism, Isolated Tissues, Organs, Cell, Proteins and Genes.
c. Computers in Clinical Development: Clinical Data Collection and
Management, Regulation of Computer Systems
5 Artificial Intelligence (AI), Robotics and Computational fluid dynamics: 12
General overview, Pharmaceutical Automation, Pharmaceutical applications,
Advantages and Disadvantages. Current Challenges and Future
Directions.
References
1. Computer Applications in Pharmaceutical Research and Development, Sean
Ekins, 2006, John Wiley & Sons.
2. Computer-Aided Applications in Pharmaceutical Technology, 1st Edition,
Jelena Djuris, Woodhead Publishing
3. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James.
G.Boylan, Marcel Dekker Inc, New York, 1996.
55
COSMETICS AND COSMECEUTICALS (MPH 204T)
Scope
This course is designed to impart knowledge and skills necessary for the
fundamental need for cosmetic and cosmeceutical products.
Course Outcome
CO1 Describe the regulatory provisions related to the import and manufacture of
cosmetics as per the Drugs and Cosmetics Act 1940 and the Rules 1945
CO2 Select key ingredients suitable in the formulation of various cosmetics
CO3 Explain the various problems related to the skin and hair
CO4 Design cosmetics that take care of cleansing needs ofthe face, eye lids, lips,
hands, feet, nail, scalp, neck, body and under-arm
CO5 Design cosmetics and cosmeceuticals with desired safety, stability and
efficacy with a knowledge of the various technologies involved in their
manufacture
CO6 Design cosmeceuticals for sun protection, dry skin, acne, sun-protection,
pigmentation, prickly heat, wrinkles, body odor. Dandruff, dental cavities,
bleeding gums, mouth odor and sensitive teeth
CO7 Select herbal ingredients in the formulation of cosmetics for hair care, skin
care and oral care
CO8 Describe the guidelines for the regulation of herbal cosmetics by private
bodies

1 Cosmetics – Regulatory: Definition of cosmetic products as per Indian 12
regulation. Indian regulatory requirements for labeling of cosmetics
Regulatory provisions relating to import of cosmetics, Misbranded and
spurious cosmetics. Regulatory provisions relating to manufacture of
cosmetics – Conditions for obtaining license, prohibition of manufacture
and sale of certain cosmetics, loan license, offences and penalties.
2 Cosmetics - Biological aspects: Structure of skin relating to problems like 12
dry skin, acne, pigmentation, prickly hat, wrinkles and body odor. Structure
of hair and hair growth cycle. Common problems associated with oral cavity.
Cleansing and care needs for face, eye lids, lips, hands, feet, nail,
scalp, neck, body and under-arm.
56
3 Formulation Building blocks: Building blocks for different 12 product 12

formulations of cosmetics/cosmeceuticals. Surfactants – Hrs Classification
and application. Emollients, rheological additives: classification and
application. Antimicrobial used as preservatives, their merits and demerits.
Factors affecting microbial preservative efficacy. Building blocks for
formulation of a moisturizing cream, vanishing cream, cold cream, shampoo
and toothpaste. Soaps and syndetbars.
Perfumes: Classification of perfumes. Perfume ingredients listed as allergens
in EU regulation.
Controversial ingredients: Parabens, formaldehyde liberators, dioxane.
4 Design of cosmeceutical products: Sun protection, sunscreens classification 12
and regulatory aspects. Addressing dry skin, acne, sun- protection,
pigmentation, prickly heat, wrinkles, body odor., dandruff, dental cavities,
bleeding gums, mouth odor and sensitive teeth through cosmeceutical
formulations.
5 Herbal Cosmetics: Herbal ingredients used in Hair care, skin care and oral 12
care. Review of guidelines for herbal cosmetics by private bodies like cosmos
with respect to preservatives, emollients, foaming agents, emulsifiers and
rheology modifiers Challenges in formulating herbal cosmetics.
References
1. Harry’s Cosmeticology. 8th edition.
2. Poucher’sperfumecosmeticsandSoaps,10th edition.
3. Cosmetics - Formulation, Manufacture and quality control, PP.Sharma,4th
edition
4. Handbook of cosmetic science and Technology A. O. Barel, M. Paye and H.I.
Maibach. 3 rd edition
5. Cosmetic and Toiletries recent suppliers catalogue.
6. CTFA directory.
57
PHARMACEUTICS PRACTICALS - II (MPH 205P)
1. To study the effect of temperature change , non solvent addition,

incompatible polymer addition in microcapsules preparation
2. Preparation and evaluation of Alginate beads
3. Formulation and evaluation of gelatin /albumin microspheres
4. Formulation and evaluation of liposomes/niosomes
5. Formulation and evaluation of spherules
6. Improvement of dissolution characteristics of slightly soluble drug by Solid
dispersion technique.
7. Comparison of dissolution of two different marketed products /brands
8. Protein binding studies of a highly protein bound drug & poorly protein
bound drug
9. Bioavailability studies of Paracetamol in animals.
10. Pharmacokinetic and IVIVC data analysis by Winnoline® Software
11. In vitro cell studies for permeability and metabolism
12. DoE Using Design Expert® Software
13. Formulation data analysis Using Design Expert® Software
14. Quality-by-Design in Pharmaceutical Development
15. Computer Simulations in Pharmacokinetics and Pharmacodynamics
16. Computational Modeling Of Drug Disposition
17. To develop Clinical Data Collection manual
18. To carry out Sensitivity Analysis, and Population Modeling.
19. Development and evaluation of Creams
20. Development and evaluation of Shampoo and Toothpaste base
21. To incorporate herbal and chemical actives to develop products
22. To address Dry skin, acne, blemish, Wrinkles, bleeding gums and dandruff
58
PHARMACEUTICAL CHEMISTRY (MPC)

(MPC 101T)
Scope
Course Outcome

CO3 Understand the basic concept and instrumentation of Chromatographic
techniques
methods
CO5 Understand the basic principles and instrumentation of fluorimeter and
atomic absorption spectrometer
CO6 Learn general principles and instrumentation of ion selective
electrodes.
CO8 Explain Instrumentation, separation and identification of compounds
by electrophoresis technique.

1 a. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 10
associated with UV-Visible spectroscopy, Choice of solvents and
solvent effect and Applications of UV-Visible spectroscopy, Difference/
Derivative spectroscopy.
59

d. Flame emission spectroscopy and Atomic absorption spectroscopy:
signals in various compounds, Chemical shift, Factors influencing chemical
shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double
resonance, Brief outline of principles of FT-NMR and 13C NMR.
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 10
parameters, factors affecting resolution, isolation of drug from excipients,
data interpretation and applications of the following:
factors affecting separation and applications of the following:
60
b. X ray Crystallography: Production of X rays, Different X ray methods,

Bragg‘s law, Rotating crystal technique, X ray powder technique, Types
of crystals and applications of X-ray diffraction.
b. Thermal Techniques: Principle, thermal transitions
andInstrumentation (Heat flux and power-compensation and designs),
applications.
References
Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley &
Sons, 1982.
61
ADVANCED ORGANIC CHEMISTRY - I (MPC 102T)
Scope
The subject is designed to provide in-depth knowledge about advances in organic
chemistry, different techniques of organic synthesis and their applications to process
chemistry as well as drug discovery.
Course Outcome
CO1 Explain the different organic intermediates involved in determining
the reaction mechanism
CO2 Explain SN1, SN2 and E1, E2 mechanism
CO3 Discuss the mechanism and applications of various named reactions
CO4 Explain the applications of various synthetic reagents
CO5 Explain the various protecting and de-protecting groups
CO6 Explain the chemistry, synthesis and mechanism of reactions in
heterocyclic compounds
CO7 Explain the principle and applications of retrosynthesis
CO8 Discuss the disconnection approach to develop synthetic routes for
small target molecule

1 Basic Aspects of Organic Chemistry: 12
1. Organic intermediates: Carbocations, carbanions, free radicals,
carbenes and nitrenes. Their method of formation, stability and
synthetic applications.
2. Types of reaction mechanisms and methods of determining them,
3. Detailed knowledge regarding the reactions, mechanisms and their
relative reactivity and orientations.
Addition reactions
a) Nucleophilic uni- and bimolecular reactions (SN1 and SN2)
b) Elimination reactions (E1 & E2; Hoffman & Saytzeff’s rule)
c) Rearrangement reaction
62
2 Study of mechanism and synthetic applications of following named 12

Reactions: Ugi reaction, Brook rearrangement, Ullmann coupling reactions,
Dieckmann Reaction, Doebner-Miller Reaction, Sandmeyer Reaction,
Mitsunobu reaction, Mannich reaction, Vilsmeyer-Haack Reaction, Sharpless
asymmetric epoxidation, Baeyer-Villiger oxidation, Shapiro & Suzuki
reaction, Ozonolysis and Michael addition reaction
3 Synthetic Reagents & Applications: Aluminiumisopropoxide, 12
N- bromosuccinamide, diazomethane, dicyclohexylcarbodimide, Wilkinson
reagent, Witting reagent. Osmium tetroxide, titanium chloride, diazopropane,
diethyl azodicarboxylate, Triphenylphosphine, Benzotriazol-
1- yloxy) tris (dimethylamino) phosphonium hexafluoro-phosphate (BOP).
Protecting groups
a. Role of protection in organic synthesis
b. Protection for the hydroxyl group, including 1,2-and1,3-diols: ethers,
esters, carbonates, cyclic acetals & ketals
c. Protection for the Carbonyl Group: Acetals and Ketals
d. Protection for the Carboxyl Group: amides and hydrazides, esters
e. Protection for the Amino Group and Amino acids: carbamates and
amides
4 Heterocyclic Chemistry: Organic Name reactions with their respective 12
mechanism and application involved in synthesis of drugs containing five, six
membered and fused hetrocyclics such as Debus-Radziszewski imidazole
synthesis, Knorr Pyrazole Synthesis Pinner Pyrimidine Synthesis, Combes
Quinoline Synthesis, Bernthsen Acridine Synthesis, Smiles rearrangement
and Traube purine synthesis.
Synthesis of few representative drugs containing these hetrocyclic nucleus
such as Ketoconazole, Metronidazole, Miconazole, celecoxib, antipyrin,
Metamizolesodium, Terconazole, Alprazolam, Triamterene, Sulfamerazine,
Trimethoprim, Hydroxychloroquine, Quinine, Chloroquine, Quinacrine,
Amsacrine, Prochlorpherazine, Promazine, Chlorpromazine, Theophylline,
Mercaptopurine and Thioguanine.
63
5 Synthon approach and retrosynthesis applications 12

i. Basic principles, terminologies and advantages of retrosynthesis;
guidelines for dissection of molecules. Functional group
interconvertion and addition (FGI and FGA)
ii. C‐X disconnections; C‐C disconnections – alcohols and carbonyl
compounds; 1,2‐, 1,3‐,1,4‐, 1,5‐, 1,6‐difunctionalized compounds
iii. Strategies for synthesis of three, four, five and six‐membered ring.
References
1. “Advanced Organic chemistry, Reaction, Mechanisms and Structure”, J March,
John Wiley and Sons, New York.
2. “Mechanism and Structure in Organic Chemistry”, ES Gould, Hold Rinchart
and Winston, New York.
3. Organic Chemistry Clayden, Greeves, Warren and Woihers., Oxford University
Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Pearson Education Lts,
Dorling Kindersley 9India) Pvt. Ltd.
5. A guide to mechanisms in Organic Chemistry, Peter Skyes (Orient Longman,
New Delhi).
6. Reactive Intermediates in Organic Chemistry, Tandom and Gowel, Oxford &
IBH Publishers.
7. Combinational Chemistry – Synthesis and applications – Stephen R Wilson &
Anthony W Czarnik, Wiley – Blackwell.
8. Carey, Organic Chemistry, 5th Edition (Viva Books Pvt. Ltd.)
9. Organic Synthesis - The Disconnection Approach, S. Warren, Wily India
10. Principles of Organic Synthesis, ROC Norman and JM Coxan, Nelson Thorns.
11. Organic Synthesis - Special Techniques. VK Ahluwalia and R Agarwal, Narosa
Publishers.
12. Organic Reaction Mechanisms IVth Edtn, VK Ahluwalia and RK Parashar,
Narosa Publishers.
64
ADVANCED MEDICINAL CHEMISTRY (MPC 103T)
Scope
The subject is designed to impart knowledge about recent advances in the field of
medicinal chemistry at the molecular level including different techniques for the
rational drug design.
Course Outcome
CO1 Learn the different stages of drug discovery & Role of medicinal
chemistry in drug research
CO2 Learn different techniques for drug discovery
CO3 Understand various strategies to design and develop a new drug like
molecules for biological targets
CO4 Explain drug receptor concept
CO5 Elaborate prodrug development and applications
CO6 Learn the structural activity relationship of the important class of
drugs
CO7 Explain types of Enzyme inhibition and its application in medicine
CO8 Discuss peptidomimetics approach and applications

1 Drug discovery: Stages of drug discovery, lead discovery; identification, 12
validation and diversity of drug targets.
Biological drug targets: Receptors, types, binding and activation, theories
of drug receptor interaction, drug receptor interactions, agonists vs
antagonists, artificial enzymes.
2 Prodrug Design and Analog design: 12
a. Prodrug design: Basic concept, Carrier linked prodrugs/
Bioprecursors, Prodrugs of functional group, Prodrugs to improve
patient acceptability, Drug solubility, Drug absorption and distribution,
site specific drug delivery and sustained drug action. Rationale of
prodrug design and practical consideration of prodrug design.
b. Combating drug resistance: Causes for drug resistance, strategies to
combat drug resistance in antibiotics and anticancer therapy, Genetic
principles of drug resistance.
c. Analog Design: Introduction, Classical & Non classical, Bioisosteric
replacement strategies, rigid analogs, alteration of chain branching,
65
changes in ring size, ring position isomers, design of stereo isomers and
geometric isomers, fragments of a lead molecule, variation in inter
atomic distance.
3 a) Medicinal chemistry aspects of the following class of drugs Systematic 12
study, SAR, Mechanism of action and synthesis of new generation
molecules of following class of drugs:
a. Anti-hypertensive drugs, Psychoactive drugs, Anticonvulsant drugs,
H1 & H2 receptor antagonist, COX1 & COX2 inhibitors,
Adrenergic & Cholinergic agents, Antineoplastic and Antiviral
agents.
b. Stereochemistry and Drug action: Realization that stereo selectivity
is a pre-requisite for evolution. Role of chirality in selective and
specific therapeutic agents. Case studies, Enantio selectivity in drug
adsorption, metabolism, distribution and
elimination.
4 Rational Design of Enzyme Inhibitors: Enzyme kinetics & Principles of 12
Enzyme inhibitors, Enzyme inhibitors in medicine, Enzyme inhibitors in
basic research, rational design of non-covalently and
covalently binding enzyme inhibitors.
5 Peptidomimetics: Therapeutic values of Peptidomimetics, design of 12
peptidomimetics by manipulation of the amino acids, modification of the
peptide backbone, incorporating conformational constraints locally or
globally. Chemistry of prostaglandins, leukotrienes and thromboxones.
References
1. Medicinal Chemistry by Burger, Vol I –VI.
2. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical
Chemistry, 12th Edition, Lppincott Williams & Wilkins, Woltess Kluwer
(India) Pvt.Ltd, New Delhi.
3. Comprehensive Medicinal Chemistry – Corwin and Hansch.
4. Computational and structural approaches to drug design edited by Robert M
Stroud and Janet. F Moore
5. Introduction to Quantitative Drug Design by Y.C. Martin.
6. Principles of Medicinal Chemistry by William Foye, 7th Edition, Ippincott
Williams & Wilkins, Woltess Kluwer (India) Pvt.Ltd, New Delhi.
7. Drug Design Volumes by Arienes, Academic Press, Elsevier Publishers,
Noida, Uttar Pradesh.
66
8. Principles of Drug Design by Smith.

9. The Organic Chemistry of the Drug Design and Drug action by Richard
B.Silverman, II Edition, Elsevier Publishers, New Delhi.
10. An Introduction to Medicinal Chemistry, Graham L.Patrick, III Edition,
Oxford University Press, USA.
11. Biopharmaceutics and pharmacokinetics, DM.Brahmankar, Sunil B. Jaiswal
II Edition, 2014, Vallabh Prakashan, New Delhi.
12. Peptidomimetics in Organic and Medicinal Chemistry by Antonio Guarna
and Andrea Trabocchi, First edition, Wiley publishers.
67
CHEMISTRY OF NATURAL PRODUCTS (MPC 104T)
Scope
The subject is designed to provide detail knowledge about chemistry of medicinal
compounds from natural origin and general methods of structural elucidation of such
compounds. It also emphasizes on isolation, purification and characterization of
medicinal compounds from natural origin.
Course Outcome
CO1 Learn the different types of alkaloids, glycosides & terpenes etc and their
chemistry and medicinal importance.
CO2 Explain the importance of natural compounds as lead molecules for new
drug discovery.
CO3 Learn the constituent present in crude drugs responsible for anti-diabetic
activity
CO4 Discuss rDNA technology tool for new drug discovery.
CO5 Explain vitamins Chemistry and Physiological significance of Vitamin
CO6 Elaborate general methods of structural elucidation of compounds of natural
origin.
CO7 Learn advanced methods of structural elucidation of compounds of natural
origin.
CO8 Understand isolation, purification and characterization of simple chemical
constituents from the natural source

1 Study of Natural products as leads for new pharmaceuticals for the 12
following class of drugs
a) Drugs Affecting the Central Nervous System: Morphine Alkaloids
b) Anticancer Drugs: Paclitaxel and Docetaxel, Etoposide, and
Teniposide
c) Cardiovascular Drugs: Lovastatin, Teprotide and Dicoumarol
d) Neuromuscular Blocking Drugs: Curare alkaloids
e) Anti-malarial drugs and Analogues
f) Chemistry of macrolid antibiotics (Erythromycin, Azithromycin,
Roxithromycin, and Clarithromycin) and β - Lactam antibiotics
(Cephalosporins and Carbapenem)
68
2 a) Alkaloids: General introduction, classification, isolation, purification, 12

molecular modification and biological activity of alkaloids, general
methods of structural determination of alkaloids, structural elucidation
and stereochemistry of ephedrine, morphine, ergot, emetine and
reserpine.
b) Flavonoids: Introduction, isolation and purification of flavonoids,
General methods of structural determination of flavonoids; Structural
elucidation of quercetin.
c) Steroids: General introduction, chemistry of sterols, sapogenin and
cardiac glycosides. Stereochemistry and nomenclature of steroids,
chemistry of contraceptive agents male & female sex hormones
(Testosterone, Estradiol, Progesterone), adrenocor-ticoids
(Cortisone), contraceptive agents and steroids (Vit – D).
3 a) Terpenoids: Classification, isolation, isoprene rule and general 12
methods of structural elucidation of Terpenoids; Structural elucidation
of drugs belonging to mono (citral, menthol, camphor), di(retinol,
Phytol, taxol) and tri terpenoids (Squalene,Ginsenoside) carotinoids (β
carotene).
b) Vitamins: Chemistry and Physiological significance of Vitamin A, B1,
B2, B12, C, E, Folic acid and Niacin.
4 a) Recombinant DNA technology and drug discovery: rDNA 12
technology, hybridoma technology, New pharmaceuticals derived from
biotechnology; Oligonucleotide therapy. Gene therapy: Introduction,
Clinical application and recent advances in gene therapy, principles of
RNA & DNA estimation
b) Active constituent of certain crude drugs used in Indigenous system
Diabetic therapy – Gymnema sylvestre, Salacia reticulate, Pterocarpus
marsupiam, Swertia chirata, Trigonella foenum graccum; Liver
dysfunction – Phyllanthus niruri; Antitumor –
Curcuma longa Linn.
5 Structural Characterization of natural compounds: Structural 12
characterization of natural compounds using IR, 1HNMR, 13CNMR and MS
Spectroscopy of specific drugs e.g., Penicillin, Morphine, Camphor,
Vit-D, Quercetin and Digitalis glycosides.
69
References
1. Modern Methods of Plant Analysis, Peech and M.V.Tracey, Springer –
Verlag, Berlin, Heidelberg.
2. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld.
3. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles,
Springer Science & Business Media.
4. Chemistry of natural products Vol I onwards IWPAC.
5. Natural Product Chemistry Nakanishi Gggolo, University Science Books,
California.
6. Natural Product Chemistry “A laboratory guide” – Rapheal Khan.
7. The Alkaloid Chemistry and Physiology by RHF Manske, Academic Press.
8. Introduction to molecular Phytochemistry – CHJ Wells, Chapmannstall.
9. Organic Chemistry of Natural Products Vol I and II by Gurdeep and
Chatwall, Himalaya Publishing House.
10. Organic Chemistry of Natural Products Vol I and II by O.P. Agarwal,
Krishan Prakashan.
11. Organic Chemistry Vol I and II by I.L. Finar, Pearson education.
12. Elements of Biotechnology by P.K. Gupta, Rastogi Publishers.
13. Pharmaceutical Biotechnology by S.P.Vyas and V.K.Dixit, CBS Publishers.
14. Biotechnology by Purohit and Mathur, Agro-Bios, 13th edition.
15. Phytochemical methods of Harborne, Springer, Netherlands.
16. Burger’s Medicinal Chemistry.
70
PHARMACEUTICAL CHEMISTRY PRACTICAL - I (MPC 105P)
1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis

spectrophotometer, RNA & DNA estimation
3. Experiments based on Column chromatography
To perform the following reactions of synthetic importance

1. Purification of organic solvents, column chromatography
2. Claisen-schimidt reaction.
3. Benzyllic acid rearrangement.
4. Beckmann rearrangement.
5. Hoffmann rearrangement
6. Mannich reaction
7. Synthesis of medicinally important compounds involving more than one
step along with purification and Characterization using TLC, melting point
and IR spectroscopy (4 experiments)
8. Estimation of elements and functional groups in organic natural
compounds
9. Isolation, characterization like melting point, mixed melting point,
molecular weight determination, functional group analysis, co-
chromatographic technique for identification of isolated compounds and
interpretation of UV and IR data.
10. Some typical degradation reactions to be carried on selected plant
constituents
71
ADVANCED SPECTRAL ANALYSIS (MPC 201T)
Scope
This subject deals with various hyphenated analytical instrumental techniques for
LC-MS, GC-MS, ATR-IR, DSC etc.
Course Outcome
CO1 Explain the theoretical principles of UV, IR ,MASS and NMR
spectroscopy
CO2 Discuss structural elucidation of organic and natural compounds by
IR, NMR and MASS spectral data
CO3 Understand the theoretical principles of Woodward-Fieser rule
CO4 Learn instrumentation and Interpretation of organic compounds by
Raman spectroscopy
CO5 Learn the general theory and principles of thermal analysis
CO6 Learn the general theory and principles of Hyphenated Techniques
CO7 Explain the general theory and principles of bioassay and ELISA
CO8 Understand principles and techniques involved in radioimmuno assay

1 UV and IR spectroscopy: Wood ward – Fieser rule for 1,3- butadienes, 12
cyclic dienes and α, β-carbonyl compounds and interpretation compounds of
enones. ATR-IR, IR Interpretation of organic compounds.
2 NMR spectroscopy: 1-D and 2-D NMR, NOESY and COSY, HECTOR, 12
INADEQUATE techniques, Interpretation of organic compounds.
3 Mass Spectroscopy: Mass fragmentation and its rules, Fragmentation of 12
important functional groups like alcohols, amines, carbonyl groups and
alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule, Isotopic
peaks, Interpretation of organic compounds.
4 Chromatography: Principle, Instrumentation and Applications of the 12
following : a) GC-MS b) GC-AAS c) LC-MS d) LC-FTIR e) LC-NMR f)
CE-MS g) High Performance Thin Layer chromatography h) Super critical
fluid chromatography i) Ion Chromatography j) I-EC (Ion-Exclusion
Chromatography) k) Flash chromatography
72
5 a) Thermal methods of analysis: Introduction, principle, instrumentation 12

and application of DSC, DTA and TGA.
b) Raman Spectroscopy: Introduction, Principle, Instrumentation and
Applications.
c) Radio immuno assay: Biological standardization, bioassay, ELISA,
Radioimmuno assay of digitalis and insulin.
References
th
Timothy A. Nieman, 5 edition, Eastern press, Bangalore, 1998.
th
3. Instrumental methods of analysis – Willards, 7 edition, CBS publishers.
rd
4. Organic Spectroscopy - William Kemp, 3 edition, ELBS, 1991.
5. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D Sethi,
CBS Publishers, New Delhi.
rd
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3
7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume
11, Marcel Dekker Series
73
ADVANCED ORGANIC CHEMISTRY - II (MPC 202T)
Scope
The subject is designed to provide in-depth knowledge about advances in organic
chemistry, different techniques of organic synthesis and their applications to process
chemistry as well as drug discovery.
Course Outcome
CO1 Discuss the principles and applications of green chemistry
CO2 Explain the chemistry, synthesis and side reactions of peptides
CO3 Explain the principles of different types of photochemical reactions
CO4 Discuss the principles of different types of pericyclic reactions
CO5 Explain the applications of homogeneous and heterogeneous catalysis
in the synthesis of drugs
CO6 Discuss the applications of biocatalysis and phase transfer catalysis in
organic reaction
CO7 Explain the basic concept of stereochemistry
CO8 Discuss the principle of asymmetric synthesis

1 Green Chemistry: 12
a. Introduction, principles of green chemistry
b. Microwave assisted reactions: Merit and demerits of its use, increased
reaction rates, mechanism, superheating effects of microwave, effects of
solvents in microwave assisted synthesis, microwave technology in
process optimization, itsapplications in various organic reactions and
heterocycles synthesis
c. Ultrasound assisted reactions: Types of sonochemical reactions,
homogenous, heterogeneous liquid-liquid and liquid-solid reactions,
synthetic applications
d. Continuous flow reactors: Working principle, advantages and synthetic
applications.
74
2 Chemistry of peptides 12
a. Coupling reactions in peptide synthesis
b. Principles of solid phase peptide synthesis, t-BOC and FMOCprotocols,
various solid supports and linkers: Activation procedures, peptide bond
formation, deprotection and cleavage from resin, low and high HF
cleavage protocols, formation of free peptides and peptide amides,
purification and case studies, site-specific chemical modifications of
peptides
c. Segment and sequential strategies for solution phase peptide synthesis
with any two case studies
d. Side reactions in peptide synthesis: Deletion peptides, side reactions
initiated by proton abstraction, protonation, over-activation and side
reactions of individual amino acids.
3 Photochemical Reactions: Basic principles of photochemical reactions. 12
Photo-oxidation, photo-addition and photo-fragmentation.
Pericyclic reactions: Mechanism, Types of pericyclic reactions such as
cyclo addition, electrocyclic reaction and sigmatrophic rearrangement
reactions with examples
4 Catalysis: 12
a. Types of catalysis, heterogeneous and homogenous catalysis,
advantages and disadvantages
b. Heterogeneous catalysis – preparation, characterization, kinetics,
supported catalysts, catalyst deactivation and regeneration, some
examples of heterogeneous catalysis used in synthesis of drugs.
c. Homogenous catalysis, hydrogenation, hydroformylation,
hydrocyanation, Wilkinson catalysts, chiral ligands and chiral induction,
Ziegler‐Natta catalysts, some examples of homogenous catalysis used
in synthesis of drugs
d. Transition-metal and Organo-catalysis in organic synthesis: Metal-
catalyzed reactions
e. Biocatalysis: Use of enzymes in organic synthesis, immobilized
enzymes/cells in organic reaction.
f. Phase transfer catalysis ‐ theory and applications
75
5 Stereochemistry & Asymmetric Synthesis 12

a. Basic concepts in stereochemistry – optical activity, specific rotation,
racemates and resolution of racemates, the Cahn, Ingold, Prelog (CIP)
sequence rule, meso compounds, pseudo asymmetric centres, axes of
symmetry, Fischers D and L notation, cis-trans isomerism, E and Z
notation.
b. Methods of asymmetric Synthesis using chiral pool, chiral auxiliaries
and catalytic asymmetric synthesis, enantiopure separation and Stereo
selective synthesis with examples.
References
1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J
March, John Wiley and sons, New York.
2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart
and Winston, NewYork.
3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers, Oxford
University Press 2001.
4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995.
5. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)
6. Organic synthesis-the disconnection approach, S. Warren, Wily India
7. Principles of organic synthesis, ROCNorman and JMCoxan, Nelson thorns
8. Organic synthesis- Special techniques VK Ahluwalia and R Aggarwal, Narosa
Publishers.
9. Organic reaction mechanisms IV edtn, VK Ahluwalia and RK Parashar,
Narosa Publishers.
76
COMPUTER AIDED DRUG DESIGN (MPC 203T)
Scope
The subject is designed to impart knowledge on the current state of the art techniques
involved in computer assisted drug design.
Course Outcome
CO1 Explain the Role of CADD in drug discovery
CO2 Understand the physicochemical Properties and the techniques involved
in QSAR
CO3 Learn the concept of molecular and quantum mechanics
CO4 Learn the working with molecular modelling softwares to design new
drug molecules
CO5 Understand in silico virtual screening protocols
CO6 Explain pharmacophore concept and the techniques involved in modeling
CO7 Learn various structure based drug design methods (Denovo drug design,
fragment based drug design)
CO8 Elaborate homology modelling and its experimental procedures

1 Introduction to Computer Aided Drug Design (CADD): History, different 12
techniques and applications.
Quantitative Structure Activity Relationships: Basics History and
development of QSAR: Physicochemical parameters and methods to
calculate physicochemical parameters: Hammett equation and electronic
parameters (sigma), lipophilicity effects and parameters (log P, pi- substituent
constant), steric effects (Taft steric and MR parameters)
Experimental and theoretical approaches for the determination of these
physicochemical parameters.
2 Quantitative Structure Activity Relationships: Applications Hansch 12
analysis, Free Wilson analysis and relationship between them, Advantages
and disadvantages; Deriving 2D-QSAR equations.
3D-QSAR approaches and contour map analysis.
Statistical methods used in QSAR analysis and importance of statistical
parameters.
77
3 Molecular Modeling and Docking 12

a) Molecular and Quantum Mechanics in drug design.
b) Energy Minimization Methods: comparison between global minimum
conformation and bioactive conformation
c) Molecular docking and drug receptor interactions: Rigid docking,
flexible docking and extra-precision docking. Agents acting on
enzymes such as DHFR, HMG-CoA reductase and HIV protease,
choline esterase ( AchE & BchE)
4 Molecular Properties and Drug Design 12
a) Prediction and analysis of ADMET properties of new molecules and
its importance in drug design.
b) De novo drug design: Receptor/enzyme-interaction and its analysis,
Receptor/enzyme cavity size prediction, predicting the functional
components of cavities, Fragment based drug design.
c) Homology modeling and generation of 3D-structure of protein.
5 Pharmacophore Mapping and Virtual Screening: Concept of 12
pharmacophore, pharmacophore mapping, identification of Pharmacophore
features and Pharmacophore modeling; Conformational search used in
pharmacophore mapping.
In Silico Drug Design and Virtual Screening Techniques
Similarity based methods and Pharmacophore based screening, structure
based In-silico virtual screening protocols.
References
1. Computational and structural approaches to drug discovery, Robert M Stroud
and Janet. F Moore, RCS Publishers.
2. Introduction to Quantitative Drug Design by Y.C. Martin, CRC Press, Taylor
& Francis group.
3. Drug Design by Ariens Volume 1 to 10, Academic Press, 1975, Elsevier
Publishers.
4. Principles of Drug Design by Smith and Williams, CRC Press, Taylor &
Francis.
5. The Organic Chemistry of the Drug Design and Drug action by Richard B.
Silverman, Elsevier Publishers.
6. Medicinal Chemistry by Burger, Wiley Publishing Co.
7. An Introduction to Medicinal Chemistry –Graham L. Patrick, Oxford
University Press.
8. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical
Chemistry, Ippincott Williams & Wilkins.
9. Comprehensive Medicinal Chemistry – Corwin and Hansch, Pergamon
Publishers.
10. Computational and structural approaches to drug design edited by Robert M
Stroud and Janet. F Moore
78
PHARMACEUTICAL PROCESS CHEMISTRY (MPC 204T)
Scope
Process chemistry is often described as scale up reactions, taking them from small
quantities created in the research lab to the larger quantities that are needed for
further testing and then to even larger quantities required for commercial production.
The goal of a process chemist is to develop synthetic routes that are safe, cost-
effective, environmentally friendly, and efficient. The subject is designed to impart
knowledge on the development and optimization of a synthetic route/s and the pilot
plant procedure for the manufacture of Active Pharmaceutical Ingredients (APIs)
and new chemical entities (NCEs) for the drug development phase.
Course Outcome
At the end of the course students will be able to…
CO1 Learn the strategies of scale up process of APIs and intermediates
CO2 Discuss the different types of unit operations in process chemistry
CO3 Carry out case study based on unit operations and unit process,
scaled up the product
CO4 Explain the various unit process in process chemistry
CO5 Learn the reaction progress kinetic analysis
CO6 Explain fermentation: Aerobic and Anaerobic
CO7 Discuss kinetics and mechanism of Nitration, Halogenation &
Oxidation
CO8 Understand the industrial safety process chemistry

1 Process chemistry: Introduction, Synthetic strategy Stages of scale up 12
process: Bench, pilot and large scale process. In-process control and
validation of large scale process. Case studies of some scale up process of
APIs. Impurities in API, types and their sources including genotoxic
impurities
2 Unit operations 12
a) Extraction: Liquid equilibria, extraction with reflux, extraction with
agitation, counter current extraction.
b) Filtration: Theory of filtration, pressure and vacuum filtration,
centrifugal filtration,
79
c) Distillation: azeotropic and steam distillation

d) Evaporation: Types of evaporators, factors affecting evaporation.
e) Crystallization: Crystallization from aqueous, non-aqueous solutions
factors affecting crystallization, nucleation. Principle and general
methods of Preparation of polymorphs, hydrates, solvates and
f) amorphous APIs.
3 Unit Processes - I 12
a) Nitration: Nitrating agents, Aromatic nitration, kinetics and mechanism
of aromatic nitration, process equipment for technical nitration, mixed
acid for nitration
b) Halogenation: Kinetics of halogenations, types of halogenations,
catalytic halogenations. Case study on industrial halogenation process.
c) Oxidation: Introduction, types of oxidative reactions, Liquid phase
oxidation with oxidizing agents. Nonmetallic Oxidizing agents such as
H2O2, sodium hypochlorite, Oxygen gas, ozonolysis.
4 Unit Processes – II 12
a) Reduction: Catalytic hydrogenation, Heterogeneous and homogeneous
catalyst; Hydrogen transfer reactions, Metal hydrides. Case study on
industrial reduction process.
b) Fermentation: Aerobic and anaerobic fermentation. Production of
Antibiotics; Penicillin and Streptomycin, Vitamins: B2 and B12
c) Statins: Lovastatin, Simvastatin Reaction progress kinetic analysis
Streamlining reaction steps, route selection, Characteristics of
expedient routes, characteristics of cost-effective routes, reagent
selection, families of reagents useful for scale-up.
5 Industrial Safety
a) MSDS (Material Safety Data Sheet), hazard labels of chemicals and
Personal Protection Equipment (PPE)
b) Fire hazards, types of fire & fire extinguishers
c) Occupational Health & Safety Assessment Series 1800 (OHSAS-
1800) and ISO-14001(Environmental Management System),
Effluents and its management
References
1. Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever-
Changing Climate-An Overview; K. Gadamasetti, CRC Press.
2. Pharmaceutical Manufacturing Encyclopedia, 3rd edition, Volume 2.
3. Medicinal Chemistry by Burger, 6th edition, Volume 1-8.
4. W.L. McCabe, J.C Smith, Peter Harriott. Unit operations of chemical
engineering, 7th edition, McGraw Hill
80
5. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed: H G

Brittain (1999)
6. Regina M. Murphy: Introduction to Chemical Processes: Principles, Analysis,
Synthesis
7. Peter J. Harrington: Pharmaceutical Process Chemistry for Synthesis:
Rethinking the Routes to Scale-Up
8. P.H.Groggins: Unit processes in organic synthesis (MGH)
9. F.A.Henglein: Chemical Technology (Pergamon)
10. M.Gopal: Dryden’s Outlines of Chemical Technology, WEP East-West Press
11. Clausen,Mattson: Principle of Industrial Chemistry, Wiley Publishing Co.,
12. Lowenheim & M.K. Moran: Industrial Chemicals
13. S.D. Shukla & G.N. Pandey: A text book of Chemical Technology Vol. II,
Vikas Publishing House
14. J.K. Stille: Industrial Organic Chemistry (PH)
15. Shreve: Chemical Process, Mc Grawhill.
16. B.K.Sharma: Industrial Chemistry, Goel Publishing House
17. ICH Guidelines
18. United States Food and Drug Administration official website www.fda.gov
81
PHARMACEUTICAL CHEMISTRY PRACTICALS – II (MPC 205P)
1. Synthesis of organic compounds by adapting different approaches involving

(3 experiments)
a) Oxidation
b) Reduction/hydrogenation
c) Nitration
2. Comparative study of synthesis of APIs/intermediates by different synthetic
routes (2 experiments)
3. Assignments on regulatory requirements in API (2 experiments)
4. Comparison of absorption spectra by UV and Wood ward – Fieser rule
5. Interpretation of organic compounds by FT-IR
6. Interpretation of organic compounds by NMR
7. Interpretation of organic compounds by MS
8. Determination of purity by DSC in pharmaceuticals
9. Identification of organic compounds using FT-IR, NMR, CNMR and Mass
spectra
10. To carry out the preparation of following organic compounds
11. Preparation of 4-chlorobenzhydrylpiperazine. (an intermediate for cetirizine
HCl).
12. Preparation of 4-iodotolene from p-toluidine.
13. NaBH4 reduction of vanillin to vanillyl alcohol
14. Preparation of umbelliferone by Pechhman reaction
15. Preparation of triphenyl imidazole
16. To perform the Microwave irradiated reactions of synthetic importance (Any
two)
17. Determination of log P, MR, hydrogen bond donors and acceptors of
selected drugs using softwares
18. Calculation of ADMET properties of drug molecules and its analysis using
softwares Pharmacophore modeling
19. 2D-QSAR based experiments
20. 3D-QSAR based experiments
21. Docking study based experiment
22. Virtual screening based experiment
82
PHARMACEUTICAL QUALITY ASSURANCE (MQA)

(MQA 101T)
Scope
Course Outcome
techniques
methods
CO6 Learn general principles and instrumentation of ion selective electrodes.
CO8 Explain Instrumentation, separation and identification of compounds by
electrophoresis technique.

1 a. UV-Visible spectroscopy: Introduction, Theory, Laws, 10
Instrumentation associated with UV-Visible spectroscopy, Choice of
solvents and solvent effect and Applications of UV-Visible
spectroscopy, Difference/ Derivative spectroscopy.
83
d. Flame emission spectroscopy and Atomic absorption

spectroscopy:
signals in various compounds, Chemical shift, Factors influencing
chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic
double resonance, Brief outline of principles of FT-NMR and 13C NMR.
4 Chromatography: Principle, apparatus, instrumentation, 10
chromatographic parameters, factors affecting resolution, isolation of drug
from excipients, data interpretation and applications of the following:
factors affecting separation and applications of the following:
b. X ray Crystallography: Production of X rays, Different X ray
methods, Bragg‘s law, Rotating crystal technique, X ray powder
technique, Types of crystals and applications of X-ray diffraction.
84

Instrumentation (Heat flux and power-compensation and designs),
applications.
References
nd
8. Spectroscopy of Organic Compounds, 2 edn., P.S/Kalsi, Wiley estern Ltd.,
Delhi.
rd
9. Textbook of Pharmaceutical Analysis, K A.Connors, 3 Edition, John Wiley
Sons, 1982.
85
QUALITY MANAGEMENT SYSTEMS (MQA 102T)
Scope
This course is designed to impart fundamental knowledge and concepts about
various quality management principles and systems utilized in the manufacturing
industry. It also aids in understanding the quality evaluation in the pharmaceutical
industries.
Course Outcome
CO1 Understand and define quality and its concept and cost involved
CO2 Learn strategic planning and implementation of quality systems
CO3 Understand the keys to customer satisfaction
CO4 Learn the various guidelines and certifications for quality
management in pharmaceuticals
CO5 Describe various tools and systems for quality management
CO6 Learn important ICH guidelines on pharmaceutical product
development and testing
CO7 Understand the concept of statistical process control in
pharmaceutical manufacturing
CO8 Learn the concept of benchmarking in quality aspect

1 Introduction to Quality: Evolution of Quality, Definition of Quality, 12
Dimensions of Quality
Quality as a Strategic Decision: Meaning of strategy and strategic quality
management, mission and vision statements, quality policy, Quality
Objectives, strategic planning and implementation, McKinsey 7s model,
Competitive analysis, Management commitment to quality
Customer Focus: Meaning of customer and customer focus, Classification
of customers, Customer focus, Customer perception of quality, Factors
affecting customer perception, Customer requirements, Meeting customer
needs and expectations, Customer satisfaction and Customer delight,
Handling customer complaints, Understanding customer behavior,
concept of internal and external customers. Case studies.
Cost of Quality: Cost of quality, Categories of cost of Quality, Models of
86
cost of quality, Optimising costs, Preventing cost of quality.

2 Pharmaceutical quality Management: Basics of Quality Management, 12
Total Quality Management (TQM), Principles of Six sigma, ISO 9001:2008,
9001:2015, ISO 14001:2004, Pharmaceutical Quality Management – ICH
Q10, Knowledge management, Quality Metrics,
Operational Excellence and Quality Management Review. OSHAS
guidelines, NABL certification and accreditation, CFR-21 part 11, WHO-
GMP requirements.
3 Six System Inspection model: Quality Management system, Production 12
system, Facility and Equipment system, Laboratory control system,
Materials system, Packaging and labeling system. Concept of self
inspection.
Quality systems: Change Management/ Change control. Deviations, Out of
Specifications (OOS), Out of Trend (OOT), Complaints - evaluation and
handling, Investigation and determination of root cause, Corrective &
Preventive Actions (CAPA), Returns and Recalls, Vendor Qualification,
Annual Product Reviews, Batch Review and Batch Release. Concept of
IPQC, area clearance/ Line clearance.
4 Drug Stability: ICH guidelines for stability testing of drug substances and 12
drug products.
Study of ICH Q8, Quality by Design and Process development report
Quality risk management: Introduction, risk ssessment, risk control, risk
review, risk management tools, HACCP, risk ranking and filtering
according to ICH Q9 guidelines.
5 Statistical Process control (SPC): Definition and Importance of SPC, 8
Quality measurement in manufacturing, Statistical control charts - concepts
and general aspects, Advantages of statistical control, Process capability,
Estimating Inherent or potential capability from a control chart analysis,
Measuring process control and quality improvement, Pursuit of decreased
process variability.
6 Regulatory Compliance through Quality Management and development of 4
Quality Culture Benchmarking: Definition of benchmarking, Reasons for
benchmarking, Types of Benchmarking, Benchmarking process,
Advantages of benchmarking, Limitations of benchmarking.
87
References
1. Implementing Juran's Road Map for Quality Leadership: Benchmarks and
Results, By Al Endres, Wiley, 2000
2. Understanding, Managing and Implementing Quality: Frameworks, Techniques
and Cases, By Jiju Antony; David Preece, Routledge, 2002
3. Organizing for High Performance: Employee Involvement, TQM,
Reengineering, and Knowledge Management in the Fortune 1000: The CEO
Report By Edward E. Lawler; Susan Albers Mohrman; George Benson, Jossey-
Bass, 2001
4. Corporate Culture and the Quality Organization By James W. Fairfield-Sonn,
Quorum Books, 2001
5. The Quality Management Sourcebook: An International Guide to Materials and
Resources By Christine Avery; Diane Zabel, Routledge, 1997
6. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
7. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De
Feo, ASQ Publications
8. Root Cause Analysis, The Core of Problem Solving and Corrective Action,
Duke Okes, 2009, ASQ Publications.
88
QUALITY CONTROL AND QUALITY ASSURANCE (MQA 103T)
Scope
This course deals with the various aspects of quality control and quality assurance
aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC
tests, documentation, quality certifications, GLP and regulatory affairs.
Course Outcome
CO1 Understand and differentiate quality control and quality assurance
CO2 Learn good laboratory practices for non clinical laboratory
CO3 Discuss GMP guidelines by various regulated countries
CO4 Learn pharmacopoeal guidelines about in process quality control
testing
CO5 Appreciate the need of documentation in pharmaceutical industry
CO6 Overview of CTDs and their requirements in regulated markets
CO7 Learn the quality assurance aspects of manufacturing and process
control
CO8 Discuss about intellectual property rights and their scope in
pharmaceutical industry

1 Introduction: Concept and evolution and Scopes of Quality Control and 12
Quality Assurance, Good Laboratory Practice, GMP, Overview of ICH
Guidelines - QSEM, with special emphasis on Q-series guidelines.
Good Laboratory Practices: Scope of GLP, Definitions, Quality assurance
unit, protocol for conduct of non clinical testing, control on animal house,
report preparation and documentation. CPCSEA guidelines.
2 cGMP guidelines according to schedule M, USFDA (inclusive of CDER and 12
CBER) Pharmaceutical Inspection Convention(PIC), WHO and EMEA
covering: Organization and personnel responsibilities, training, hygiene and
personal records, drug industry location, design, construction and plant lay
out, maintenance, sanitation, environmental control, utilities and maintenance
of sterile areas, control of contamination and Good Warehousing Practice.
89
3 Analysis of raw materials, finished products, packaging materials, in process 12

quality control (IPQC), Developing specification (ICH Q6 and Q3), purchase
specifications and maintenance of stores for raw materials. In process quality
control and finished products quality control for following dosage forms in
Pharma industry according to Indian, US and British pharmacopoeias: tablets,
capsules, ointments, suppositories, creams, parenterals, ophthalmic and
surgical products (How to refer pharmacopoeias).
4 Documentation in pharmaceutical industry: Three tier documentation, 12

Policy, Procedures and Work instructions, and records (Formats), Basic
principles- How to maintain, retention and retrieval etc. Standard operating
procedures (How to write), Master Batch Record, Batch Manufacturing
Record, Quality audit plan and reports. Specification and test procedures,
Protocols and reports. Distribution records. Electronic data handling.
Concepts of controlled and uncontrolled documents. Submission documents
for regulators DMFs, as Common Technical Document and Electronic
Common Technical Documentation (CTD, eCTD). Concept of regulated
and non regulated markets.
5 Manufacturing operations and controls: Sanitation of manufacturing 12
premises, mix-ups and cross contamination, processing of intermediates and
bulk products, packaging operations, IPQC, release of finished product,
process deviations, charge-in of components, time limitations on production,
drug product inspection, expiry date calculation, calculation of yields,
production record review, change control, sterile products, aseptic process
control, packaging, reprocessing, salvaging, handling of waste and scrap
disposal. Introduction, Scope and importance of intellectual property rights.
Concept of trade mark, copyright and patents.
References
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of
India, 3rd revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69,
Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and
Related materials Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
90
5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of

Analysis and Quality specification for Pharmaceutical Substances, Excepients
and Dosage forms, 3rd edition, WHO, Geneva, 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel
Dekker Series, 1989.
7. ICH guidelines
8. ISO 9000 and total quality management
9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th edition,
Susmit Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality
control – Sidney H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers
and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software
Package). Taylor & Francis; 2003.
13. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley &
Sons; 2008.
14. Packaging of Pharmaceuticals.
15. Schedule M and Schedule N.
91
PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER

(MQA 104T)
Scope
This deal with technology transfer covers the activities associated with Drug
Substance, Drug Product and analytical tests and methods, required following
candidate drug selection to completion of technology transfer from R&D to the first
receiving site and technology transfer related to post-marketing changes in
manufacturing places.
Course Outcome
CO1 Learn the regulatory principles and requirements of drug discovery
and developments
CO2 Understand the concept of preformulation studies for various
formulations
CO3 Concept and designing of pilot plants and product scale up
CO4 Leant various pharmaceutical packaging systems and their quality
testing
CO5 Learn the concept of technology transfer from R&D to production
plant
CO6 Discuss on the new era opportunities and challenges in the
pharmaceutical market
CO7 Know the basics of stability studies during formulation development
CO8 Learnt the product registration guidelines in India and USA

1 Principles of Drug discovery and development: Introduction, Clinical 12
research process. Development and informational content for
Investigational New Drugs Application (IND), New Drug Application
(NDA), Abbreviated New Drug Application (ANDA), Supplemental New
Drug Application (SNDA), Scale Up Post Approval Changes (SUPAC) and
Bulk active chemical Post approval changes (BACPAC), Post marketing
surveillance, Product registration guidelines – CDSCO, USFDA.
92
2 Pre-formulation studies: Introduction/concept, organoleptic properties, 12

purity, impurity profiles, particle size, shape and surface area. Solubility,
Methods to improve solubility of Drugs: Surfactants & its importance, co-
solvency. Techniques for the study of Crystal properties and polymorphism.
Pre-formulation protocol, Stability testing during product development.
3 Pilot plant scale up: Concept, Significance, design, layout of pilot plant 12
scale up study, operations, large scale manufacturing techniques (formula,
equipment, process, stability and quality control) of solids, liquids,
semisolid and parenteral dosage forms. New era of drug products:
opportunities and challenges.
4 Pharmaceutical packaging: Pharmaceutical dosage form and their 12
packaging requirments, Pharmaceutical packaging materials, Medical
device packaging, Enteral Packaging, Aseptic packaging systems, Container
closure systems, Issues facing modern drug packaging, Selection and
evaluation of Pharmaceutical packaging materials. Quality control test:
Containers, closures and secondary packing materials.
5 Technology transfer: Development of technology by R & D, Technology 12
transfer from R & D to production, Optimization and Production,
Qualitative and quantitative technology models. Documentation in
technology transfer: Development report, technology transfer plan and
Exhibit.
References
1. The process of new drug discovery and development. I and II Edition (2006)
by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor
and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial
Pharmacy. Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuticals (A Plan for total quality control) 3rd
Edition. Bhalani publishing house Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B.
Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo
Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza.
93
Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.

7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack
Publishing company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th
Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer
Company, Philadelphia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied
Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall.
1st Edition (Reprint 2006). Taylor and Francis. London and New York.
94
QUALITY ASSURANCE PRACTICAL - I (MQA 105P)
1. Analysis of Pharmacopoeial compounds in bulk and in their

formulations (tablet/ capsules/ semisolids) by UV Vis
spectrophotometer
2. Simultaneous estimation of multi-drug component containing
formulations by UV spectrophotometry
6. Estimation of sodium/potassium by flame photometry or AAS
7. Case studies on
• Total Quality Management
• Six Sigma
• Change Management/ Change control. Deviations,
• Out of Specifications (OOS)
• Out of Trend (OOT)
• Corrective & Preventive Actions (CAPA)
• Deviations
8. Development of Stability study protocol
9. Estimation of process capability
10. In process and finished product quality control tests for tablets,
capsules, parenterals and semisolid dosage forms.
11. Assay of raw materials as per official monographs
12. Testing of related and foreign substances in drugs and raw materials
13. To carry out pre formulation study for tablets, parenterals (2 experiment)
14. To study the effect of pH on the solubility of drugs, (1 experiment)
15. Quality control tests for Primary and secondary packaging materials
16. Accelerated stability studies (1 experiment)
17. Improved solubility of drugs using surfactant systems (1 experiment)
18. Improved solubility of drugs using co-solvency method (1 experiment)
19. Determination of Pka and Log p of drugs.
95
HAZARDS AND SAFETY MANAGEMENT (MQA 201T)
Scope
This course is designed to convey the knowledge necessary to understand issues
related to different kinds of hazard and their management. Basic theoretical and
practical discussions integrate the proficiency to handle the emergency situation in
the pharmaceutical product development process and provides the principle based
approach to solve the complex tribulations.
Course Outcome
CO1 Learn the multidisciplinary nature of environmental studies and
various natural resources
CO2 Understand the concept of an ecosystem and structure and function of
an ecosystem
CO3 Learn about sources and types of air based hazards
CO4 Understand the prevention of fire hazards and critical hazard
management systems
CO5 Learn the types of chemical based hazards and their prevention
CO6 Discuss the management and prevention of fire and explosion
CO7 Learn the hazard risk management in workplace
CO8 Learn the rules and guidelines on risk assessment and management

1 Multidisciplinary nature of environmental studies: Natural Resources, 12
Renewable and non-renewable resources, Natural resources and associated
problems,
a) Forest resources; b) Water resources; c) Mineral resources; d) Energy
resources; e) Land resources
Ecosystems: Concept of an ecosystem and Structure and function of an
ecosystem. Environmental hazards: Hazards based on Air, Water, Soil and
Radioisotopes.
2 Air based hazards: Sources, Types of Hazards, Air circulation maintenance 12
industry for sterile area and non sterile area, Preliminary Hazard Analysis (PHA)
Fire protection system: Fire prevention, types of fire extinguishers and
critical Hazard management system.
96
3 Chemical based hazards: Sources of chemical hazards, Hazards of Organic 12

synthesis, sulphonating hazard, Organic solvent hazard, Control measures for
chemical hazards, Management of combustible gases, Toxic gases and Oxygen
displacing gases management, Regulations for chemical hazard, Management
of over-Exposure to chemicals and TLV concept.
4 Fire and Explosion: Introduction, Industrial processes and hazards potential, 12
mechanical electrical, thermal and process hazards. Safety and hazards
regulations, Fire protection system: Fire prevention, types of fire extinguishers
and critical Hazard management system mechanical and chemical explosion,
multiphase reactions, transport effects and global rates. Preventive and
protective management from fires and explosion-electricity passivation,
ventilation, and sprinkling, proofing, relief systems -relief valves, flares,
scrubbers.
5 Hazard and risk management: Self-protective measures against workplace 12
hazards. Critical training for risk management, Process of hazard management,
ICH guidelines on risk assessment and Risk management methods and Tools
Factory act and rules, fundamentals of accident prevention, elements of safety
programme and safety management, Physicochemical measurements of
effluents, BOD, COD, Determination of some contaminants, Effluent
treatment procedure, Role of emergency services.
References
1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers,
Bangalore
2. “Quantitative Risk Assessment in Chemical Process Industries” American
Institute of Chemical Industries, Centre for Chemical Process safety.
3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd.,
Ahmedabad – 380 013, India,
4. Hazardous Chemicals: Safety Management and Global Regulations, T.S.S.
Dikshith, CRC press
97
PHARMACEUTICAL VALIDATION (MQA 202T)
Scope
The main purpose of the subject is to understand about validation and how it can be
applied to industry and thus improve the quality of the products. The subject covers
the complete information about validation, types, methodology and application.
Course Outcome
CO1 Understand the concepts of calibration, qualification and validation
CO2 Know about the qualification of various pharmaceutical equipments and
instruments
CO3 Study the Process validation of different dosage forms
CO4 Understand Validation of analytical method for estimation of drugs
CO5 Understand Cleaning validation of equipments employed in the
manufacture of pharmaceuticals
CO6 Understand Intellectual property rights and patent filing
CO7 Know about the concept of Qualification of laboratory instruments
CO8 Understand validation of sterile and non sterile plant and computerized
system validation

1 Introduction to validation: Definition of Calibration, Qualification and 10
Validation, Scope, frequency and importance. Difference between calibration
and validation. Calibration of weights and measures. Advantages of
Validation, Scope of Validation, Organization for Validation, Validation
Master plan, Types of Validation, Streamlining of qualification & Validation
process and Validation Master Plan.
Qualification: User requirement specification, Design qualification, Factory
Acceptance Test (FAT)/Site Acceptance Test (SAT), Installation
qualification, Operational qualification, Performance qualification, Re-
Qualification (Maintaining status-Calibration Preventive Maintenance,
Change management).
98
2 Qualification of manufacturing equipment: Dry Powder Mixers, Fluid Bed 10

and Tray dryers, Tablet Compression (Machine), Dry heat
sterilization/Tunnels, Autoclaves, Membrane filtration, Capsule filling
machine.
Qualification of analytical instruments: UV-Visible spectrophotometer,
FTIR, DSC, GC, HPLC, HPTLC, LC-MS.
3 Qualification of laboratory equipments: Hardness tester, Friability test 10
apparatus, tap density tester, Disintegration tester, Dissolution test apparatus
Validation of Utility systems: Pharmaceutical water system & pure steam,
HVAC system, Compressed air and nitrogen.
4 Process Validation: Concept, Process and documentation of Process 10
Validation. Prospective, Concurrent & Retrospective Validation, Re
validation criteria, Process Validation of various formulations (Coated
tablets, Capsules, Ointment/Creams, Liquid Orals and aerosols.), Aseptic
filling: Media fill validation, USFDA guidelines on Process Validation- A
life cycle approach.
Analytical method validation: General principles, Validation of analytical
method as per ICH guidelines and USP.
5 Cleaning Validation: Cleaning Method development, Validation of 10
analytical method used in cleaning, Cleaning of Equipment, Cleaning of
Facilities. Cleaning in place (CIP).
Validation of facilities in sterile and non-sterile plant. Computerized
system validation: Electronic records and digital signature - 21 CFR Part
11 and GAMP
6 General Principles of Intellectual Property: Concepts of Intellectual 10
Property (IP), Intellectual Property Protection (IPP), Intellectual Property
Rights (IPR); Economic importance, mechanism for protection of Intellectual
Property –patents, Copyright, Trademark; Factors affecting choice of IP
protection; Penalties for violation; Role of IP in pharmaceutical industry;
Global ramification and financial implications. Filing a patent applications;
patent application forms and guidelines. Types patent applications-
provisional and non provisional, PCT and convention patent applications;
International patenting requirement procedures and costs; Rights and
responsibilities of a patentee; Practical aspects regarding maintaining of a
Patent file; Patent infringement meaning and Scope. Significance of transfer
technology (TOT), IP and ethics-positive and negative aspects of IPP;
Societal responsibility, avoiding unethical practices.
99
References
1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and
Pharm Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.
2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman,
Herbert A. Lieberman, Joseph. L. Karig, Varghese Publishing House,
Bombay.
3. Validation Master plan by Terveeks or Deeks, Davis Harwood International
publishing.
4. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton &
Agalloco
5. Michael Levin, Pharmaceutical Process Scale-Up”, Drugs and Pharm. Sci.
Series, Vol. 157,2nd Ed., Marcel Dekker Inc., N.Y.
6. Validation Standard Operating Procedures: A Step by Step Guide for
Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech
Industries, Syed Imtiaz Haider
7. Pharmaceutical Equipment Validation: The Ultimate Qualification
Handbook, Phillip A. Cloud, Interpharm Press
8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J.
Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker
9. Analytical Method validation and Instrument Performance Verification by
Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience.
10. Huber L. Validation and Qualification in Analytical Laboratories. Informa
Healthcare
11. Wingate G. Validating Corporate Computer Systems: Good IT Practice for
Pharmaceutical Manufacturers. Interpharm Press
12. LeBlanc DA. Validated Cleaning Technologies for Pharmaceutical
Manufacturing. Interpharm Press
100
AUDITS AND REGULATORY COMPLIANCE (MQA 203T)
Scope
This course deals with the understanding and process for auditing in pharmaceutical
industries. This subject covers the methodology involved in the auditing process of
different in pharmaceutical industries.
Course Outcome
CO1 Discuss briefly about audit objectives and their management
CO2 Understand the role of quality systems and audits in pharmaceutical
manufacturing environment
CO3 Frame a checklist for auditing pharmaceutical industries
CO4 Lean the requirements for auditing vendors supplying various materials and
equipments
CO5 Understand the audition of a microbiological laboratory
CO6 Learn the auditing of quality assurance systems
CO7 Understand the basics of auditing various engineering systems in a
manufacturing plant
CO8 Learn about audit report and classification of deficiencies

1 Introduction: Objectives, Management of audit, Responsibilities, 12
Planning process, information gathering, administration, Classifications of
deficiencies
2 Role of quality systems and audits in pharmaceutical manufacturing 12
environment: cGMP Regulations, Quality assurance functions, Quality
systems approach, Management responsibilities, Resource, Manufacturing
operations, Evaluation activities, Transitioning to quality system approach,
Audit checklist for drug industries
3 Auditing of vendors and production department: Bulk Pharmaceutical 12
Chemicals and packaging material Vendor audit, Warehouse and weighing,
Dry Production: Granulation, tableting, coating, capsules, sterile
production and packaging.
4 Auditing of Microbiological laboratory: Auditing the manufacturing 12
process, Product and process information, General areas of
interest in the building raw materials, Water, Packaging materials
101
5 Auditing of Quality Assurance and engineering department: Quality 12

Assurance Maintenance, Critical systems: HVAC, Water, Water for
Injection systems, ETP.
References
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and
Gil Bismuth, Interpharm/CRC, Boca Raton, London New York, Washington
D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by
Shayne Cox Gad. Wiley-Interscience, A John Wiley and sons, Inc.,
Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman
A. Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer,
Raluca- loana Stefan, Jacobus F. Van Staden. Taylor and Francis (2005).
102
PHARMACEUTICAL MANUFACTURING TECHNOLOGY

(MQA 204T)
Scope
This course is designed to impart knowledge and skills necessary to train the students
with the industrial activities during Pharmaceutical Manufacturing.
Course Outcome
CO1 Understand the basics of developing a pharmaceutical industry
CO2 Learn the basics of plant layout and production planning
CO3 Learn the basics of aseptic process technology in pharmaceutical
manufacturing
CO4 Discussion of advance sterile manufacturing technologies
CO5 Learn the process automation and lyophilization in sterile
manufacturing
CO6 Discuss the basic and advanced technologies for non sterile product
manufacturing and coating
CO7 Learn the quality aspects of pharmaceutical containers and closures
CO8 Detailed discussion on Quality by design (QbD) and process analytical
technology

1 Pharmaceutical industry developments: Legal requirements and 12
Licenses for API and formulation industry, Plant location- Factors
influencing.
Plant layout: Factors influencing, Special provisions, Storage space
requirements, sterile and aseptic area layout.
Production planning: General principles, production systems,
calculation of standard cost, process planning, routing, loading,
scheduling, dispatching of records, production control.
2 Aseptic process technology: Manufacturing, manufacturing flowcharts, 12
in process-quality control tests for following sterile dosage forms:
Ointment, Suspension and Emulsion, Dry powder, Solution (Small
Volume & large Volume).
Advanced sterile product manufacturing technology : Area planning
& environmental control, wall and floor treatment, fixtures and
machineries, change rooms, personnel flow, utilities & utilities equipment
103
location, engineering and maintenance.

Process Automation in Pharmaceutical Industry: With specific
reference to manufacturing of sterile semisolids, Small Volume
Parenterals & Large Volume Parenterals (SVP & LVP), Monitoring of
Parenteral manufacturing facility, Cleaning in Place (CIP),
Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet, Needle Free
Injections, and Form Fill Seal Technology (FFS).
Lyophilization technology: Principles, process, equipment.
3 Non sterile manufacturing process technology: Manufacturing, 12
manufacturing flowcharts, in process-qualitycontrol tests for following
Non-Sterile solid dosage forms: Tablets (compressed & coated), Capsules
(Hard & Soft).
Advance non-sterile solid product manufacturingtechnology: Process
Automation in Pharmaceutical Industry withspecific reference to
manufacturing of tablets and coatedproducts, Improved Tablet
Production: Tablet production process, granulation and pelletization
equipments, continuous and batchmixing, rapid mixing granulators, rota
granulators, spheronizersand marumerisers, and other specialized
granulation and drying equipments. Problems encountered.
Coating technology: Process, equipments, particle coating, Fluidized
bed coating, application techniques. Problems encountered
4 Containers and closures for pharmaceuticals: Types, performance, 12
assuring quality of glass; types of plastics used, Drug plastic interactions,
biological tests, modification of plastics by drugs; different types of
closures and closure liners; film wrapper; blister packs; bubble packs;
shrink packaging; foil / plastic pouches, bottle seals, tape seals, breakable
seals and sealed tubes; quality control of packaging material and filling
equipment, flexible packaging, product package compatibility, transit
worthiness of package, Stability aspects of packaging. Evaluation of
stability of packaging material.
5 Quality by design (QbD) and process analytical technology (PAT): 12
Current approach and its limitations. Why QbD is required, Advantages,
Elements of QbD. Terminology: QTPP. CMA, CQA, CPP, RLD, Design
space, Design of Experiments, Risk Assessment and
mitigation/minimization. Quality by Design, Formulations by Design,
QbD for drug products, QbD for Drug Substances, QbD for Excipients,
Analytical QbD. FDA initiative on process analytical technology. PAT as
a driver for improving quality and reducing costs: quality by design
104
(QbD), QA, QC and GAMP. PAT guidance, standards and regulatory

requirements.
References
1. Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial
pharmacy, 3rd ed., Varghese Publishers, Mumbai 1991.
2. Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences, 5 ed., B.I.
Publications Pvt. Ltd, Noida, 2006.
3. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms: tablets
Vol. I- III, 2nd ed., CBS Publishers & distributors, New Delhi, 2005.
4. Banker GS, Rhodes CT. Modern Pharmaceutics, 4 ed., Marcel Dekker Inc, New
York, 2005.
5. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good
manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition.
Bhalani publishing house Mumbai.
6. Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
7. British Pharmacopoeia. British Pharmacopoeia Commission Office, London,
2008.
8. United States Pharmacopoeia. United States Pharmacopeial Convention, Inc,
USA, 2003.
9. Dean D A, Evans E R and Hall I H. Pharmaceutical Packaging Technology.
London, Taylor & Francis, 1st Edition. UK.
10. Edward J Bauer. Pharmaceutical Packaging Handbook. 2009. Informa Health
care USA Inc. New york.
11. Shaybe Cox Gad. Pharmaceutical Manufacturing Handbook. John Willey and
Sons, New Jersey, 2008.
105
QUALITY ASSURANCE PRACTICAL – II PRACTICALS

(MQA 205P)
1. Organic contaminants residue analysis by HPLC

2. Estimation of Metallic contaminants by Flame photometer
3. Identification of antibiotic residue by TLC
4. Estimation of Hydrogen Sulphide in Air.
5. Estimation of Chlorine in Work Environment.
6. Sampling and analysis of SO2 using Colorimetric method
7. Qualification of following Pharma equipment
a. Autoclave
b. Hot air oven
c. Powder Mixer (Dry)
d. Tablet Compression Machine
8. Validation of an analytical method for a drug
9. Validation of a processing area
10. Qualification of at least two analytical instruments
11. Cleaning validation of one equipment
12. Qualification of Pharmaceutical Testing Equipment (Dissolution testing
apparatus, Friability Apparatus, Disintegration Tester)
13. Check list for Bulk Pharmaceutical Chemicals vendors
14. Check list for tableting production.
15. Check list for sterile production area
16. Check list for Water for injection.
17. Design of plant layout: Sterile and non-sterile
18. Case study on application of QbD
19. Case study on application of PAT
106
PHARMACEUTICAL REGULATORY AFFAIRS (MRA)

GOOD REGULATORY PRACTICES (MRA 101T)
Scope
This course is designed to impart fundamental knowledge on various Good
Regulatory Practices viz., cGMP, GLP, GALP and GDP for Pharmaceuticals,
Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical
Devices (IVDs) and biological products and understand the rationale behind these
requirements and will propose ways and means of complying with them.
Course Outcome
CO1 Prepare checklists and SOPs for various good regulatory practices.
CO2 Develop good regulatory practices in the healthcare and related
industries
CO3 Demonstrate a plan for the readiness and conduct of audits and
inspections.
CO4 Categorize the key regulatory and compliance elements with respect to
GMP.
GLP.
GALP.
GDP.
CO8 Describe the quality management system in the Pharmaceutical
Industry.

1 Current Good Manufacturing Practices: Introduction, US cGMP 12
Part 210 and Part 211.EC Principles of GMP (Directive 91/356/EEC)
Article 6 to Article 14 and WHO cGMP guidelines GAMP-5; Medical
device and IVDs Global Harmonization Task Force(GHTF) Guidance
docs.
107
2 Good Laboratory Practices: Introduction, USFDA GLP Regulations 12

(Subpart A to Subpart K), Controlling the GLP inspection process,
Documentation, Audit, goals of Laboratory Quality Audit, Audit tools,
Future of GLP regulations, relevant ISO and Quality Council of India
(QCI) Standards
3 Good Automated Laboratory Practices: Introduction to GALP, 12
Principles of GALP, GALP Requirements, SOPs of GALP, Training
Documentation, 21 CFR Part 11, General check list of 21CFR Part 11,
Software Evaluation checklist, relevant ISO and QCI Standards.
4 Good Distribution Practices: Introduction to GDP, Legal 12

GDPRequirements put worldwide, Principles, Personnel,
Documentation, Premises and Equipment, Deliveries to Customers,
Returns, Self-Inspection, Provision of information, Stability testing
principles, WHO GDP, USP GDP (Supply chain integrity), relevant
CDSCO guidance and ISO standards
5 Quality management systems: Concept of Quality, Total Quality 12

Management, Quality by design, Six Sigma concept, Out of
Specifications (OOS), Change control. Validation: Types of Validation,
Types of Qualification, Validation master plan (VMP), Analytical
Method Validation. Validation of utilities, [Compressed air, steam,
water systems, Heat Ventilation and Air conditioning (HVAC)]and
Cleaning Validation. The International Conference on Harmonization
(ICH) process, ICH guidelines to establish quality, safety and efficacy
of drug substances and products, ISO 13485, Sch MIII and other
relevant CDSCO regulatory guidance documents.
References
1. Good Laboratory Practice Regulations, by Sandy Weinberg, Fourth Edition
Drugs and the Pharmaceutical Sciences, Vol.168
2. Good Pharmaceutical Manufacturing practice, Rational and compliance by
John Sharp, CRC Press
3. Establishing a cGMP Laboratory Audit System, A practical Guide by David
M.Bleisner, Wiley Publication.
4. How to practice GLP by PP Sharma, Vandana Publications.
5. Laboratory Auditing for Quality and Regulatory compliance bu Donald
C.Singer, Drugs and the Pharmaceutical Sciences, Vol.150.
6. Drugs & Cosmetics Act, Rules & Amendments
108
DOCUMENTATION AND REGULATORY WRITING (MRA 102T)
Scope
This course is designed to impart fundamental knowledge on documentation and
general principles involved in regulatory writing and submission to agencies.
Course Outcome
CO1 Discuss the basic Documentation in pharmaceutical industry
CO2 Discuss on dossier preparation and CTD submission
CO3 Learn about eCTD and technologies available
CO4 Understand the basics of CTD submission in India through Sugam system
CO5 Learn the basics of internal and external audits
CO6 Learn ISO standards and guidelines on audits
CO7 Understand inspection systems in pharmaceutical companies and follow up
actions
CO8 Learn the regulatory aspects of product lifecycle management and product
recalls

1 Documentation in pharmaceutical industry: Exploratory Product 12
Development Brief (EPDB) for Drug substance and Drug product,
Product Development Plan (PDP), Product Development Report
(PDR), Master Formula Record, Batch Manufacturing Record and its
calculations, Batch Reconciliation, Batch Packaging Records, Print
pack specifications, Distribution records, Certificate of Analysis
(CoA), Site Master File and Drug Master Files (DMF).
2 Dossier preparation and submission: Introduction and overview of 12
dossiers, contents and organization of dossier, binders and sections,
compilation and review of dossier. Paper submissions, overview and
modules of CTD, electronic CTD submissions; Electronic submission:
Planning electronic submission, requirements for submission,
regulatory bindings and requirements, Tool and Technologies,
electronic dossier submission process and validating the submission,
Electronic Submission Gateway (ESG). Non eCTD electronic
submissions (NeeS), Asian CTD formats (ACTD) submission.
Organizing, process and validation of submission.
109
Submission in Sugam system of CDSCO.

3 Audits: Introduction, Definition, Summary, Types of audits, GMP 12
compliance audit, Audit policy, Internal and External Audits, Second
Party Audits, External third party audits, Auditing strategies,
Preparation and conducting audit, Auditing strategies, audit analysis,
audit report, audit follow up. Auditing/inspection of manufacturing
facilities by regulatory agencies. Timelines for audits/inspection.
GHTF study group 4 guidance document. ISO 13485.
4 Inspections: Pre-approval inspections, Inspection of pharmaceutical 12
manufacturers, Inspection of drug distribution channels, Quality
systems requirements for national good manufacturing practice
inspectorates, inspection report, model certificate of good
manufacturing practices, Root cause analysis, Corrective and
Preventive action (CAPA).
5 Product life cycle management: Prior Approval Supplement (PAS), 12
Post Approval Changes [SUPAC], Changes Being Effected in 30 Days
(CBE-30), Annual Report, Post marketing Reporting Requirements,
Post approval Labeling Changes, Lifecycle Management, FDA
Inspection and Enforcement, Establishment Inspection Report (EIR),
Warning Letters, Recalls, Seizure and Injunctions. ISO Risk
Management Standard
References
1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury
and Gil Bismuth, Interpharm/CRC, Boca Raton, London New York,
Washington D.C.
2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by
Shayne Cox Gad. Wiley-Interscience, A John Wiley and sons, Inc.,
Publications.
3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman
A. Hodges, Stephen P. Denyar. CRC Press. 2000.
4. Laboratory auditing for quality and regulatory compliance. Donald C.
Singer, Raluca- loana Stefan, Jacobus F. Van Staden. Taylor and Francis
(2005).
5. Implementing Juran's Road Map for Quality Leadership: Benchmarks and
Results, By Al Endres, Wiley, 2000
6. Understanding, Managing and Implementing Quality: Frameworks,
Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
110
7. Organizing for High Performance: Employee Involvement, TQM,

Reengineering, and Knowledge Management in the Fortune 1000: The CEO
Report By Edward E. Lawler; Susan Albers Mohrman; George Benson,
Jossey-Bass, 2001
8. Corporate Culture and the Quality Organization By James W. Fairfield-
Sonn, Quorum Books, 2001
9. The Quality Management Sourcebook: An International Guide to Materials
and Resources By Christine Avery; Diane Zabel, Routledge, 1997
10. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications.
11. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De
Feo, ASQ Publications
12. Root Cause Analysis, The Core of Problem Solving and Corrective Action,
Duke Okes, 2009, ASQ Publications
13. International Medical Device Regulators Forum (IMDRF) Medical Device
Single Audit Program (MDSAP)
111
CLINICAL RESEARCH REGULATIONS (MRA 103T)
Scope
This course is designed to impart the fundamental knowledge on the clinical
development process of drugs, pharmaceuticals and Medical Devices, phases and
conduct of clinical trials and research, regulations and guidance governing the
conduct of clinical research in India, USA and EU. It prepares the students to learn
in detail on various laws, legislations and guidance related to safety, efficacy, ethical
conduct and regulatory approval of clinical research.
Course Outcome
CO1 Understand the History, origin and ethics of clinical and biomedical
research and evaluation
CO2 Know Clinical drug, medical device development process, different types
and phases of clinical trials
CO3 Know the regulatory requirements and guidance for conduct of clinical trials
and research.
CO4 Understand the European union guidance for clinical evaluation and safety
for medicinal products and medical devices.
CO5 Understand the clinical, ethical principles, informed consent form, process
and documentation.
CO6 Know the General biostatic principles applied in clinical research.
CO7 Understand FDA guidance for bioavailability and bioequivalence
requirements for medicinal products
CO8 Understand Indian GCP, CDSCO and ICMR guidelines for biomedical
research.

1 Clinical Drug Development Process 12
• Different types of Clinical Studies
• Phases of clinical trials, Clinical Trial protocol
• Phase 0 studies
• Phase I and subtype studies (single ascending, multiple ascending,
dose escalation, methods, food effect studies, drug – drug
interaction, PK end points
• Phase II studies (proof of concept or principle studies to establish
112
efficacy)
• Phase III studies (Multi ethnicity, global clinical trial, registration
studies)
• Phase IV studies (Post Marketing Studies; PSUR)
Clinical Investigation and Evaluation of Medical Devices & IVDs
Different Types of Studies, Key Concepts of Medical Device Clinical
Evaluation, Key concepts of Clinical Investigation
2 Ethics in Clinical Research: 12
• Historical Perspectives: Nuremberg Code, Thalidomide study,
Nazis Trials, Tuskegee Syphilis Study, The Belmont Report,
The declaration of Helsinki
• Origin of International Conference on Harmonization - Good
Clinical Practice (ICH-GCP) guidelines.
• The ethics of randomized clinical trials
• The role of placebo in clinical trials
• Ethics of clinical research in special population
• Institutional Review Board/Independent Ethics Committee/ Ethics
Committee – composition, roles, responsibilities, review and
approval process and ongoing monitoring of safety data
• Data safety monitoring boards.
• Responsibilities of sponsor, CRO, and investigator in ethical
conduct of clinical research
• Ethical principles governing informed consent process
• Patient Information Sheet and Informed Consent Form
• The informed consent process and documentation
3 Regulations governing Clinical Trials 12
India: Clinical Research regulations in India – Schedule Y & Medical
Device Guidance
USA: Regulations to conduct drug studies in USA (FDA)
• NDA 505(b)(1) of the FD&C Act (Application for approval of a
new drug)
• NDA 505(b)(2) of the FD&C Act (Application for approval of a new
drug that relies, at least in part, on data not developed by the
applicant)
• ANDA 505(j) of the FD&C Act (Application for approval of a
generic drug product)
• FDA Guidance for Industry – Acceptance of Foreign Clinical
113
Studies
• FDA Clinical Trails Guidance Document: Good Clinical Practice
EU: Clinical Research regulations in European Union (EMA)
4 Clinical Research Related Guidelines 12
• Good Clinical Practice Guidelines (ICH GCP E6)
• Indian GCP Guidelines
• ICMR Ethical Guidelines for Biomedical Research
• CDSCO guidelines
GHTF study group 5 guidance documents
Regulatory Guidance on Efficacy and Safety ICH Guidance’s
• E4 – Dose Response Information to support Drug Registration
• E7 – Studies in support of General Population: Geriatrics
• E8 – General Considerations of Clinical Trials
• E10 – Choice of Control Groups and Related Issues in Clinical
Trials,
• E 11 – Clinical Investigation of Medicinal Products in the Pediatric
Population
• General biostatics principle applied in clinical researc
5 USA & EU Guidance 12
USA: FDA Guidance
• CFR 21Part 50: Protection of Human Subjects
• CFR 21Part 54: Financial Disclosure by Clinical Investigators
• CFR 21Part 312: IND Application
• CFR 21Part 314: Application for FDA Approval to Market a New
Drug
• CFR 21Part 320: Bioavailability and bioequivalence
requirements
• CFR 21Part 812: Investigational Device Exemptions
• CFR 21Part 822: Post-market surveillance
• FDA Safety Reporting Requirements for INDs and BA/BE Studies
• FDA Med Watch
• Guidance for Industry: Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment
European Union: EMA Guidance
• EU Directives 2001
• EudraLex (EMEA) Volume 3 – Scientific guidelines for medicinal
products for human use
• EU Annual Safety Report (ASR)
114
• Volume 9A – Pharmacovigilance for Medicinal Products for

Human Use
• EU MDD with respect to clinical research
• ISO 14155
References
1. Clinical Trials and Human Research: A Practical Guide to Regulatory
Compliance By Fay A. Rozovsky and Rodney K. Adams
2. HIPAA and Human Subjects Research: A Question and Answer Reference
Guide By Mark Barnes, JD, LLM and Jennifer Kulynych, JD, PhD
3. Principles and Practices of Clinical Research, Second Edition Edited by John
I. Gallin and Frederick P. Ognibene
4. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE
Karlberg and Marjorie A Speers; Karlberg, Johan Petter Einar, Hong Kong.
5. International Pharmaceutical Product Registration: Aspects of Quality,
Safety and Efficacy; Anthony C. Cartwright; Taylor & Francis Inc., USA.
6. New Drug Approval Process: The Global Challenge; Guarino, Richard A;
Marcel Dekker Inc., NY.
biologics; Douglas J. Pisano, David Mantus; CRC Press, USA
8. Country Specific Guidelines from official websites.
9. Drugs & Cosmetics Act & Rules and Amendments
Recommended websites:
1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc
/clinical- eudirective-04-april-01.pdf
2. Code of Federal Regulations, FDA: http://www.accessdata.fda.gov/scripts
/cdrh/cfdocs/cfcfr/cfrsearch.cfm
3. Guidelines of International Conference on Harmonization: http://www.
ich.org/products/guidelines.html
4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.html
5. FDA New Drug Application: http://www.fda.gov/regulatoryinformation
/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterV
Drugs andDevices/ucm108 125.htm
6. Medicines and Healthcare products Regulatory Agency:
http://www.mhra.gov.uk
115
7. Central Drugs Standard Control Organization Guidance for Industry:

http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
8. ICMR Ethical Guidelines for Biomedical Research: http://icmr.nic.in
/ethical_guidelines.pdf
116
DRUGS REGULATIONS AND OTHER LEGISLATION IN INDIA

AND INTELLECTUAL PROPERTY RIGHTS (MRA 104T)
Scope
This course is designed to impart fundamental knowledge on regulations and
legislation in India w.r.t. Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals. It prepares the students for basic regulatory
requirements in India of Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals. for manufacture, import & registration, export,
sale, marketing authorization, clinical trials and intellectual property rights.
Course Outcome
CO1 Assess the approval process and regulatory requirements for drugs &
cosmetics, medical devices, biological & herbals, and food &
nutraceuticals
CO2 Examine the Indian Pharmacopoeial and BIS standards
CO3 Review and validate the guidelines for drug testing in animals
CO4 Practice the concept of Intellectual Property Rights
CO5 Describe the different acts and guidelines that regulate drugs & cosmetics,
medical devices, biological & herbals, and food & nutraceuticals industry
in India
CO6 Categorize the guidelines for drug testing in animals
CO7 Assess the regulatory requirements for bioequivalence study
CO8 Describe the role of IPR in regulatory affairs.

1 Biologicals & Herbals, and Food & Nutraceuticals Acts and Rules 12
(with latest amendments):
1. Drugs and Cosmetics Act 1940 and Rules 1945: DPCO and NPPA
2. Other relevant provisions (rules schedules and guidelines for
approval of Drugs & Cosmetics, Medical Devices, Biologicals &
Herbals, and Food & Nutraceuticals in India
Other relevant Acts: Narcotics Drugs and Psychotropic Substances Act;
Medicinal and Toilet Preparations (Excise Duties) Act, 1955; Pharmacy
Act, 1948; Drugs and Magic Remedies (Objectionable
Advertisements) Act, 1955; Prevention of Cruelty to Animals Act.
117
2 Regulatory requirements and approval procedures for Drugs & 12

Cosmetics Medical Devices, Biologicals & Herbals, and Food &
Nutraceuticals: CDSCO (Central Drug Standard Control Organization)
and State Licensing Authority: Organization, Responsibilities Rules,
regulations, guidelines and standards for regulatory filing of Drugs &
Cosmetics, Medical Devices, Biologicals & Herbals, and Food &
Nutraceuticals Format and contents of Regulatory dossier filing Clinical
trial/ investigations
3 Indian Pharmacopoeial Standards, BIS standards and ISO and other 12
relevant standards
4 Bioavailability and Bioequivalence data (BA &BE), BCS Classification 12
of Drugs, Regulatory Requirements for Bioequivalence study
Stability requirements: ICH and WHO
Guidelines for Drug testing in animals/Preclinical Studies Animal
testing: Rationale for conducting studies, CPCSEA Guidelines Ethical
guidelines for human participants ICMR-DBT Guidelines for Stem Cell
Research
5 Intellectual Property Rights: Patent, Trademark, Copyright, Industrial 12
Designs and Geographical Indications, Indian Patent Scenario. IPR vs
Regulatory Affairs
References
1. Manual of Patent Practice & Procedure, 3rd Edition, by The Patent Office
of India
2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at risk
by James Bessen and Michael J. Meurer
3. Principles and Practice of Clinical Trial Medicine by Richard Chin and
Bruce Y. Lee
4. Ethical Guidelines for Biomedical Research on Human Participants by
Indian Council of Medical Research New delhi 2006.
5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the
purpose of control and supervision on experiments on animals (CPCSEA)
6. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite
7. Guidance for Industry on Submission of Clinical Trial Application for
Evaluating Safety and Efficacy by CDSCO (Central Drug Standard Control
Organisation)
118
8. Guidance for Industry on Requirement of Chemical & Pharmaceutical

Information including Stability Study Data before approval of clinical trials
/ BE studies by CDSCO
9. Guidelines for Import and Manufacture of Medical Devices by CDSCO
10. Guidelines from official website of CDSCO
119
REGULATORY AFFAIRS PRACTICAL - I (MRA 105P)
1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.

2. Documentation for in process and finished products Quality control tests for
Solid, liquid, Semisolid and Sterile preparations.
3. Preparation of SOPs, Analytical reports (Stability and validation)
4. Protocol preparation for documentation of various types of records (BMR,
MFR, DR)
5. Labeling comparison between brand & generics.
6. Preparation of clinical trial protocol for registering trial in India
7. Registration for conducting BA/ BE studies in India
8. Import of drugs for research and developmental activities
9. Preparation of regulatory dossier as per Indian CTD format and submission
in SUGAM
10. Registering for different Intellectual Property Rights in India
11. GMP Audit Requirements as per CDSCO
12. Preparation and documentation for Indian Patent application.
13. Preparation of checklist for registration of IND as per ICH CTD format.
14. Preparation of checklist for registration of NDA as per ICH CTD format.
15. Preparation of checklist for registration of ANDA as per ICH CTD format.
16. Case studies on response with scientific rationale to USFDA Warning Letter
17. Preparation of submission checklist of IMPD for EU submission.
18. Comparison study of marketing authorization procedures in EU.
19. Comparative study of DMF system in US, EU and Japan
20. Preparation of regulatory submission using eCTD software
21. Preparation of Clinical Trial Application (CTA) for US submission
22. Preparation of Clinical Trial Application (CTA) for EU submission
23. Comparison of Clinical Trial Application requirements of US, EU and Japan
of a dosage form.
24. Regulatory requirements checklist for conducting clinical trials in India.
25. Regulatory requirements checklist for conducting clinical trials in Europe.
26. Regulatory requirements checklist for conducting clinical trials in USA
120
REGULATORY ASPECTS OF DRUGS & COSMETICS (MRA 201T)
Scope
This course is designed to impart the fundamental knowledge on the drug
development process, regulatory requirements for approval of new drugs, drug
products and cosmetics in regulated and semi-regulated countries. It prepares the
students to learn in detail on the regulatory requirements, documentation
requirements, and registration procedures for marketing the drug products and
cosmetics in regulated and semi-regulated countries.
Course Outcome
CO1 Study the regulatory approval process and registration procedures for
API and drug products in USA and Canada
CO2 Explain the role of various committees across the globe ( APEC,
EAC, GCC, PANDRH, SADC)
CO3 Know the legislation and regulations for import, manufacture,
distribution and sale of drugs and cosmetics in EU and Australia
CO4 Understand the cosmetics regulations in regulated and semi-regulated
countries
CO5 Understand the legislation and regulations for manufacturing,
packaging and labelling of pharmaceuticals in Japan
CO6 Describe the requirements for registration of drugs and post
approval requirements in ASEAN countries
CO7 Study the regulatory prerequisites related to Marketing authorization
requirements for drugs and post approval requirements in CIS
countries
CO8 Understand the concept of Certificate of Pharmaceutical
Product(CoPP) in General and Country Specific

1 USA & CANADA: Organization structure and functions of FDA. 12
Federal register and Code of Federal Regulations (CFR), History
and evolution of United States Federal, Food, Drug and Cosmetic
Act (FFDCA), Hatch Waxman act and Orange book, Purple book,
Drug Master Files (DMF) system in US, Regulatory Approval
Process for Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application
(ANDA), Supplemental New Drug Application (SNDA);
121
Regulatory requirements for Orphan drugs and Combination

Products, Changes to an approved NDA / ANDA. Regulatory
considerations for manufacturing, packaging and labeling of
pharmaceuticals in USA. Legislation and regulations for import,
manufacture, distribution and sale of cosmetics in USA and
Canada.
2 European Union & Australia: Organization and structure of 12
EMA & EDQM, General guidelines, Active Substance Master
Files (ASMF) system in EU, Content and approval process of
IMPD, Marketing Authorization procedures in EU (Centralized
procedure, Decentralized procedure, Mutual recognition
procedure and National Procedure). Regulatory considerations for
manufacturing, packaging and labeling of pharmaceuticals in EU,
Eudralex directives for human medicines, Variations &
extensions, Compliance of European Pharmacopoeia (CEP)/
Certificate of Suitability (CoS), Marketing Authorization (MA)
transfers, Qualified Person (QP) in EU. Legislation and
regulations for import, manufacture, distribution and sale of
cosmetics in European Union & Australia.
3 Japan: Organization of the PMDA, Pharmaceutical Laws and 12
regulations, types of registration applications, DMF system in
Japan, drug regulatory approval process, Regulatory
considerations for manufacturing, packaging and labeling of
pharmaceuticals in Japan, Post marketing surveillance in Japan.
Legislation and regulations for import, manufacture, distribution
and sale of cosmetics in Japan
4 Emerging Market: Introduction, Countries covered, Study of the 12
world map,study of various committees across the globe (ASEAN,
APEC, EAC, GCC, PANDRH, SADC)
WHO: WHO, GMP, Regulatory Requirements for registration of
drugs and post approval requirements in WHO through
prequalification programme, Certificate of Pharmaceutical
Product(CoPP) - General and Country Specific (South Africa,
Egypt, Algeria and Morocco, Nigeria, Kenya and Botswana)
122
5 Brazil, ASEAN, CIS and GCC Countries: 12

ASIAN Countries: Introduction to ACTD, Regulatory
Requirements for registration of drugs and post approval
requirements in China and South Korea & Association of
Southeast Asian Nations (ASEAN) Region i.e. Vietnam,
Malaysia, Philippines, Singapore and Thailand.
CIS (Commonwealth Independent States): Regulatory pre-
requisites related to Marketing authorization requirements for
drugs and post approval requirements in CIS countries i.e. Russia,
Kazakhstan and Ukraine GCC (Gulf Cooperation Council) for
Arab states: Regulatory pre-requisites related to Marketing
authorization requirements for drugs and post approval
requirements in Saudi Arabia and UAE
Legislation and regulations for import, manufacture,
distribution and sale of cosmetics in Brazil, ASEAN, CIS and
GCC Countries.
References:
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel
and Isader Kaufer, Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel
Dekker Series, Vol.144
3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R.
Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences, Vol.185
Informa Health care Publishers.
4. New Drug Approval Process: Accelerating Global Registrations By Richard
A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
5. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley
& Sons. Inc.
6. Drugs: From Discovery to Approval, Second Edition By Rick Ng
7. New Drug Development: A Regulatory Overview, Eighth Edition By Mark
Mathieu
8. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines
and Gary H. Slatko
9. Preparation and Maintenance of the IND Application in eCTD Format By
William K. Sietsema
10. Country Specific Guidelines from official websites. http://www.who.int/
medicines/areas/quality_safety/regulation_legislation/ ListMRAWebsites.pdf
123
11. Roadmap to an ASEAN economic community Edited by Denis Hew. ISEAS

Publications, Singapore 2005, ISBN981-230-347-2
12. ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN
978-981- 230-750-7
13. Building a Future with Brics: The Next Decade for Offshoring, Mark
Kobayashi-Hillary, Springer
14. Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary,
Springer Trade performance and Regional Integration of the CIS Countries,
Lev Freinkman,
15. The world Bank, Washington, DC, ISBN: 0-8212-5896-0
16. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World By
Frederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes 139
17. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by
Linda Low and Lorraine Carlos Salazar (Nov 22, 2010)
18. Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press
ISBN:13:978-1-60649-108-9
19. Realizing the ASEAN Economic Community: A Comprehensive Assessment,
Michael G Plummer (Editor), Chia Siow Yue (Editor), Institute of South east
asian studies, Singapore
124
REGULATORY ASPECTS OF HERBAL AND BIOLOGICALS

(MRA 202T)
Scope
This course is designed to impart fundamental knowledge on Regulatory
Requirements, Licensing and Registration, Regulation on Labelling of
Biologics in India, USA and Europe
It prepares the students to learn in detail on Regulatory Requirements for
biologics, Vaccines and Blood Products
Course Outcome
At the end of course students will be able to…
CO1 Recognize the regulation for newly developed biologics and biosimilars.
CO2 Explain the pre-clinical and clinical development considerations of biologics.
CO3 Discuss the regulatory requirements of blood and/or its components including
blood products and label requirements.
CO4 Set up the quality and safety of herbal products.
CO5 Describe the regulatory requirements for biologics and vaccines.
CO6 Describe the regulatory requirements for the herbal products.
CO7 Set up the quality and safety of herbal products.
CO8 Set up the legislation for herbal products.

1 India : Introduction, Applicable Regulations and Guidelines , 12
Principles for Development of Similar Biologics, Data Requirements
for Preclinical Studies, Data Requirements for Clinical Trial
Application, Data Requirements for Market Authorization
Application, Post-Market Data for Similar Biologics,
Pharmacovigilance. GMP and GDP.
2 USA: Introduction to Biologics; biologics, biological and biosimilars, 12
different biological products, difference between generic drug and
biosimilars, laws, regulations and guidance on biologics/ biosimilars,
development and approval of biologics and biosimilars (IND, PMA,
BLA, NDA, 510(k), pre-clinical and clinical development
considerations, advertising, labelling and packing of biologics
125
3 European Union: Introduction to Biologics; directives, scientific 12

guidelines and guidance related to biologics in EU,
comparability/biosimilarity assessment, Plasma master file, TSE/ BSE
evaluation, development and regulatory approval of biologics
(Investigational medicinal products and biosimilars), pre-clinical and
clinical development considerations; stability, safety, advertising,
labelling and packing of biologics in EU
4 Vaccine regulations in India, US and European Union: Clinical 12
evaluation, Marketing authorisation, Registration or licensing, Quality
assessment, Pharmacovigilance, Additional requirements Blood and
Blood Products Regulations in India, US and European Union:
Regulatory Requirements of Blood and/or Its Components Including
Blood Products, Label Requirements, ISBT (International Society of
Blood Transfusion) and IHN (International Haemovigilence Network)
5 Herbal Products: Quality, safety and legislation for herbal products 12

in India, USA and European Union.
References
1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices,
and Biologics, Douglas J. Pisano , David S. Mantus ; Informa ,2008
2. Biological Drug Products: Development and Strategies; Wei Wang ,
Manmohan Singh ; wiley ,2013
3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan
Singh , Indresh K. Srivastava ;Wiley, 2011
4. www.who.int/biologicals/en
5. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInfo
rmation/
6. www.ihn-org.com
7. www.isbtweb.org
8. Guidelines on Similar Biologics: Regulatory Requirements for Marketing
Authorization in India
9. www.cdsco.nic.in
10. www.ema.europa.eu › scientific guidelines › Biologicals
11. www.fda.gov/biologics bloodVaccines/Guidance Compliance Regulatory
Information (Biologics)
126
REGULATORY ASPECTS OF MEDICAL DEVICES (MRA 203T)
Scope
This course is designed to impart the fundamental knowledge on the medical devices
and in vitro diagnostics, basis of classification and product life cycle of medical
devices, regulatory requirements for approval of medical devices in regulated
countries like US, EU and Asian countries along with WHO regulations. It prepares
the students to learn in detail on the harmonization initiatives, quality and ethical
considerations, regulatory and documentation requirements for marketing medical
devices and IVDs in regulated countries.
Course Outcome
CO1 Know the basics of medical devices and IVDs, process of development,
ethical and quality considerations.
CO2 Know the quality system regulations and quality risk management of
medical devices.
CO3 Know the medical devices and IVDs directives in European Union and
USA.
CO4 Understand organizational structure, regulatory guidelines and functions
of IMDRF/GHTF.
CO5 Know Harmonization initiatives for approval and marketing of medical
devices and IVDs.
CO6 Understand regulatory approval process for medical devices and IVDs in
India, US, and Europe.
CO7 Know clinical evaluation and investigation of medical devices and IVDs.
CO8 Understand regulatory approval process for medical devices and IVDs in
China, Japan and ASEAN countries.

1 Medical Devices: Introduction, Definition, Risk based 12
classification and Essential Principles of Medical Devices and IVDs.
Differentiating medical devices IVDs and Combination Products
from that of pharmaceuticals, History of Medical Device
Regulation, Product Lifecycle of Medical Devices and
Classification of Medical Devices.
127
IMDRF/GHTF: Introduction, Organizational Structure, Purpose

and Functions, Regulatory Guidelines, Working Groups, Summary
Technical Document (STED), Global Medical DeviceNomenclature
(GMDN).
2 Ethics: Clinical Investigation of Medical Devices, Clinical 12
Investigation Plan for Medical Devices, Good Clinical Practice for
Clinical Investigation of medical devices (ISO 14155:2011)
Quality: Quality System Regulations of Medical Devices: ISO
13485, Quality Risk Management of Medical Devices: ISO 14971,
Validation and Verification of Medical device, Adverse Event
Reporting of Medical device
3 USA: Introduction, Classification, Regulatory approval process for 12
Medical Devices (510k) Premarket Notification, Pre-Market
Approval (PMA), Investigational Device Exemption (IDE) and In
vitro Diagnostics, Quality System Requirements 21 CFR Part 820,
Labeling requirements 21 CFR Part 801, Post marketing
surveillance of MD and Unique Device Identification (UDI).
Basics of In vitro diagnostics, classification and approval process.
4 European Union: Introduction, Classification, Regulatory approval 12
process for Medical Devices (Medical Device Directive, Active
Implantable Medical Device Directive) and In vitro Diagnostics (In
Vitro Diagnostics Directive), CE certification process. Basics of In
vitro diagnostics, classification and approval process.
5 ASEAN, China & Japan: Medical Devices and IVDs, Regulatory 12
registration procedures, Quality System requirements and clinical
evaluation and investigation. IMDRF study groups and guidance
documents.
References
biologics by Douglas J. Pisano, David Mantus.
2. Medical Device Development: A Regulatory Overview by Jonathan S. Kahan
3. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical
Devices by John J. Tobin and Gary Walsh
4. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics
by Carmen Medina
128
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS

(MRA 204T)
Scope
This course is designed to impart the fundamental knowledge on Regulatory
Requirements, Registration and Labeling Regulations of Nutraceuticals in India,
USA and Europe.
It prepares the students to learn in detail on Regulatory Aspects for nutraceuticals
and food supplements.
Course Outcome
CO1 Define and differentiate nutraceuticals, functional foods, dietary
supplements, and medical foods
CO2 Discuss the scope and opportunities in nutraceutical market
CO3 Learn the history of nuraceuticals and their regulations
CO4 Learn the global aspects of regulations in food and nutraceutical markets
CO5 Understand the nutraceutical regulations in India
CO6 Learn the nutraceutical regulations in USA
CO7 Study the nutraceutical regulations in European Union
CO8 Understand and compare the Recommended Dietary Allowance in various
regulated countries

1 Nutraceuticals: Introduction, History of Food and Nutraceutical 12
Regulations, Meaning of Nutraceuticals, Dietary Supplements,
Functional Foods, Medical Foods, Scope and Opportunities in
Nutraceutical Market.
2 Global Aspects: WHO guidelines on nutrition. NSF International: Its 12
Role in the Dietary Supplements and Nutraceuticals Industries, NSF
Certification, NSF Standards for Food And Dietary Supplements.
Good Manufacturing Practices for Nutraceuticals.
3 India: Food Safety and Standards Act, Food Safety and Standards 12
Authority of India: Organization and Functions, Regulations for
import, manufacture and sale of nutraceutical products in India,
Recommended Dietary Allowances (RDA) in India.
129
4 USA: US FDA Food Safety Modernization Act, Dietary Supplement 12

Health and Education Act. U.S. regulations for manufacture and sale
of nutraceuticals and dietary supplements, Labelling Requirements
and Label Claims for Dietary Supplements, Recommended Dietary
Allowances (RDA) in the U.S
5 European Union: European Food Safety Authority (EFSA):
Organization and Functions. EU Directives and regulations for
manufacture and sale of nutraceuticals and dietary supplements.
Nutrition labelling. European Regulation on Novel Foods and Novel
Food Ingredients. Recommended Dietary Allowances (RDA) in
Europe.
References
1. Regulation of Functional Foods and Nutraceuticals: A Global Perspective by
Clare M. Hasler (Wiley Online Library)
2. Nutraceutical and Functional Food Regulations in the United States and
Around the World by Debasis Bagchi (Academic Press, Elsevier)
3. http://www.who.int/publications/guidelines/nutrition/en/
4. http://www.europarl.europa.eu/RegData/etudes/STUD/2015/536324/IPOL_S
TU(2015)5 36324_EN.pdf
5. Handbook of Nutraceuticals by Yashwant Pathak (CRC Press)
6. Food Regulation: Law, Science, Policy and Practice by Neal D. Fortin (Wiley)
130
REGULATORY AFFAIRS PRACTICAL - II (MRA 205P)
1. Case studies
2. Change Management/ Change control. Deviations
3. Corrective & Preventive Actions (CAPA)
4. Documentation of raw materials analysis as per official monographs
5. Preparation of audit checklist for various agencies
6. Preparation of submission to FDA using eCTD software
7. Preparation of submission to EMA using eCTD software
8. Preparation of submission to MHRA using eCTD software
9. Preparation of Biologics License Applications (BLA)
10. Preparation of documents required for Vaccine Product Approval
11. Comparison of clinical trial application requirements of US, EU and India
of Biologics
12. Preparation of Checklist for Registration of Blood and Blood Products
13. Registration requirement comparison study in 5 emerging markets (WHO)
and preparing check list for market authorization
14. Registration requirement comparison study in emerging markets (BRICS)
15. Registration requirement comparison study in emerging markets (China
and South Korea) and preparing check list for market authorization
16. Registration requirement comparison study in emerging markets
(ASEAN) and preparing check list for market authorization
17. Registration requirement comparison study in emerging markets (GCC)
18. Checklists for 510k and PMA for US market
19. Checklist for CE marking for various classes of devices for EU
20. STED Application for Class III Devices
21. Audit Checklist for Medical Device Facility
22. Clinical Investigation Plan for Medical Devices
131
PHARMACY PRACTICE (MPP)

CLINICAL PHARMACY PRACTICE (MPP 101T)
Scope
This course is designed to impart the basic knowledge and skills that are required to
practice pharmacy including the provision of pharmaceutical care services to both
healthcare professionals and patients in clinical settings.
Course Outcome
CO1 Describe the elements of pharmaceutical care and patient care services
CO2 Interpret the laboratory results to aid the clinical diagnosis of various
disorders
CO3 Discuss the organization and functions of drug and poison information
centers.
CO4 Formulate, analyze and interpret the drug and poison information
CO5 Develop the practice skills for providing patient care services
CO6 Assess the drug therapy of patient through medication chart review and
clinical review
CO7 Describe patient counselling and medication history interview
CO8 Understand the concept of pharmacovigilance, hemovigilance,
materiovigilance and adverse event following immunization

1 Introduction to Clinical Pharmacy: Definition, evolution and Scope of 12
clinical pharmacy, International and national scenario of clinical
pharmacy practice, Pharmaceutical care
Clinical Pharmacy Services: Ward round participation, Drug therapy
review (Drug therapy monitoring including medication order review,
chart endorsement, clinical review and pharmacist interventions)
132
2 Clinical Pharmacy Services: Patient medication history interview, 12

Basic concept of medicine and poison information services, Basic
concept of pharmacovigilance, Hemovigilance, Materiovigilance and
AEFI, Patient medication counselling, Drug utilisation evaluation,
Documentation of clinical pharmacy services, Quality assurance of
clinical pharmacy services.
3 Patient Data Analysis: 12
Patient Data & Practice Skills: Patient's case history - its structure and
significances in drug therapy management, Common medical
abbreviations and terminologies used in clinical practice,
Communication skills: verbal and non-verbal communications, its
applications in patient care services.
Lab Data Interpretation: Hematological tests, Renal function tests,
Liver function tests
4 Lab Data Interpretation: Tests associated with cardiac disorders, 12
Pulmonary function tests, Thyroid function tests, Fluid and electrolyte
balance, Microbiological culture sensitivity tests
5 Medicines & Poison Information Services 12
Medicine Information Service: Definition and need for medicine
information service, Medicine information resources, Systematic
approach in answering medicine information queries, Preparation of
verbal and written response, Establishing a drug information centre.
Poison Information Service: Definition, need, organization and
functions of poison information centre.
References
1. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills –
Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata
2. Practice Standards and Definitions - The Society of Hospital Pharmacists of
Australia
3. Basic skills in interpreting laboratory data - Scott LT, American Society of
Health System Pharmacists Inc
4. Relevant review articles from recent medical and pharmaceutical literature.
133
PHARMACOTHERAPEUTICS-I (MPP 102T)
Scope
This course aims to enable the students to understand the different treatment
approaches in managing various disease conditions. Also, it imparts knowledge and
skills in optimizing drug therapy of a patient by individualizing the treatment plan
through evidence-based medicines.
Course Outcome
CO1 Describe the Etiopathogenesis of selected disease states
CO2 Discuss the various methods involved in the diagnosis of selected disease
state
CO3 Interpret and analyze the selected laboratory results of specific disease
states
CO4 Describe the therapeutic approach to manage the selected diseases
CO5 Discuss the rationale for drug therapy of the selected disease
CO6 Identify the controversies in drug therapy
CO7 Develop the individualized therapeutic plans based on diagnosis
CO8 Identify the patient-specific parameters relevant in initiating the drug
therapy

Etiopathogenesis and pharmacotherapy of diseases associated with following systems
1 Cardiovascular system: Hypertension, Congestive cardiac failure, Acute 12
coronary syndrome, Arrhythmias, Hyperlipidemias
2 Respiratory system: Asthma, Chronic obstructive airways disease, 12
Drug induced pulmonary diseases Endocrine system: Diabetes, Thyroid
diseases
3 Gastrointestinal system: Peptic ulcer diseases, Reflux esophagitis, 12
Inflammatory bowel diseases, Jaundice & hepatitis
4 Gastrointestinal system: Cirrhosis, Diarrhea and Constipation, Drug- 12
induced liver disease
Hematological diseases: Anemia, Deep vein thrombosis, Drug induced
hematological disorders
134
5 Bone and joint disorders: Rheumatoid arthritis, Osteoarthritis, Gout, 12

Osteoporosis
Dermatological Diseases: Psoriasis, Eczema and scabies, impetigo, drug
induced skin disorders
Ophthalmology: Conjunctivitis, Glaucoma
References
1. Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill
Livingstone publication
2. Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach-
Appleton & Lange
3. Robins SL. Pathologic basis of disease -W.B. Saunders publication
4. Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and
Wilkins Publication
5. Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use
of Drugs- Lippincott Williams and Wilkins
6. Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro.
Pharmacotherapy Principles and practice-– McGraw Hill Publication
7. Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams
and Wilkins
8. Harrison's. Principles of Internal Medicine - McGraw Hill
9. Relevant review articles from recent medical and pharmaceutical literature
135
HOSPITAL & COMMUNITY PHARMACY (MPP 103T)
Scope
This course is designed to impart basic knowledge and skills that are required to
practice pharmacy in both hospital and community settings.
Course Outcome
CO1 Describe the organizational structure of hospital & hospital pharmacy
CO2 Explain different drug policies & committees in the hospital
CO3 Operate various drug distribution methods in the hospital
CO4 Explain management of inventory control in the hospital pharmacy
CO5 Describe the management of community pharmacy
CO6 Analyse and manage the prescriptions in the hospital & community
pharmacy
CO7 Recognize the minor ailments and develop the health promotions in the
community
CO8 Describe health promotions in community

1 Introduction to Hospitals – Definition, classification, 12
organizational structure
Hospital Pharmacy: Definition, Relationship of hospital pharmacy
department with other departments, Organizational structure, legal
requirements, work load statistics, Infrastructural requirements,
Hospital Pharmacy Budget and Hospital Pharmacy management
Hospital Drug Policy: Pharmacy & Therapeutics Committee,
Infection Control committee, Research & Ethics Committee,
Management of Medicines as per NABH
2 Hospital Formulary Guidelines and its development, Developing 12
Therapeutic guidelines, Drug procurement process, and methods of
Inventory control, Methods of Drug distribution, Intravenous
admixtures, Hospital Waste Management
136
3 Education and training: Training of technical staff, training and 12

continuing education for pharmacists, Pharmacy students, Medical
staff and students, Nursing staff and students, Formal and informal
meetings and lectures, Drug and therapeutics newsletter.
Community Pharmacy Practice: Definition, roles &
responsibilities of community pharmacists, and their relationship
with other health care providers.
Community Pharmacy management: Legal requirements to start
community pharmacy, site selection, lay out & design, drug display,
super drug store model, accounts and audits, Good dispensing
practices, Different softwares & databases used in community
pharmacies. Entrepreneurship in community pharmacy.
4 Prescription – Legal requirements & interpretation, prescription 12

related problems
Responding to symptoms of minor ailments: Head ache, pyrexia,
menstrual pains, food and drug allergy
OTC medication: Rational use of over the counter medications
Medication counseling and use of patient information leaflets
Medication adherence – Definition, factors influencing adherence
behavior, strategies to improve medication adherence Patient
referrals to the doctors ADR monitoring in community pharmacies
5 Health Promotion – Definition and health promotion activities, 12
family planning, Health screening services, first aid, prevention of
communicable and non-communicable diseases, smoking cessation,
Child & mother care
National Health Programs- Role of Community Pharmacist in
Malaria and TB control programs
Home Medicines review program – Definition, Objectives,
Guidelines, method and outcomes
Research in community pharmacy Practice
References
1. Hospital Pharmacy - Hassan WE. Lea and Febiger publication.
2. Textbook of hospital pharmacy - Allwood MC and Blackwell.
3. Avery’s Drug Treatment, Adis International Limited.
4. Community Pharmacy Practice – Ramesh Adepu, BSP Publishers, Hyderabad
5. Remington Pharmaceutical Sciences.
137
CLINICAL RESEARCH (MPP 104T)
Scope
This course aims to provide the students an opportunity to learn drug development
process especially the phases of clinical trials and also the ethical issues involved in
the conduct of clinical research. Also, it aims to imparts knowledge and develop
skills on conceptualizing, designing, conducting and managing clinical trials.
Course Outcome
CO1 Describe the concept of new drug development process
CO2 Recognize the regulatory and ethical requirements in clinical trials
CO3 Describe the types of research designs in clinical research
CO4 Recognize the roles and responsibilities of clinical trial study team
CO5 Develop the various clinical trial documents
CO6 Discuss various procedures and activities involved in the conduct of
clinical trials
CO7 Explain the quality assurance and quality control activities in clinical
research
CO8 Interpret the various aspects of clinical trial data management.

1 Drug development process: Introduction, various approaches to 12
drug discovery, Investigational new drug application submission
Ethics in Biomedical Research: Ethical Issues in Biomedical
Research – Principles of ethics in biomedical research, Ethical
committee [institutional review board] - its constitution and
functions, Challenges in implementation of ethical guidelines, ICH
GCP guidelines and ICMR guidelines in conduct of Clinical trials,
Drug Safety Reporting.
138
2 Types and Designs used in Clinical Research: Planning and 12

execution of clinical trials, Various Phases of clinical trials,
Bioavailability and Bioequivalence studies, Randomization
techniques (Simple randomization, restricted randomization,
blocking method and stratification), Types of research designs based
on Controlling Method (Experimental, Quasi experimental, and
Observational methods) Time Sequences (Prospective and
Retrospective), Sampling methods (Cohort study, case Control study
and cross sectional study), Health outcome measures (Clinical &
Physiological, Humanistic and economic)
Clinical Trial Study team: Roles and responsibilities of:
Investigator, Study Coordinator, Sponsor, Monitor, Contract
Research Organization.
3 Clinical trial Documents: Guidelines to the preparation of 12
following documents: Protocols, Investigator’s Brochure, Informed
Consent Form, Case report forms, Contracts and agreements, Dairy
Cards
Clinical Trial Start up activities: Site Feasibility Studies,
Site/Investigator selection, Pre-study visit, Investigator meeting,
Clinical trial agreement execution, Ethics committee document
preparation and submission
4 Investigational Product: Procurement and Storage of 12
investigation product
Filing procedures: Essential documents for clinical trial, Trial
Master File preparation and maintenance, Investigator Site File,
Pharmacy File, Site initiation visit, Conduct, Report and Follow up
Clinical Trial Monitoring and Close out:
Preparation and conduct of monitoring visit: Review of source
documents, CRF, ICF, IP storage, accountability and reconciliation,
Study Procedure, EC communications, Safety reporting, Monitoring
visit reporting and follow-up
Close-Out visit: Study related documents collection, Archival
requirement, Investigational Product reconciliation and destruction,
Close-Out visit report.
139
5 Quality Assurance and Quality Control in Clinical Trials: Types 12

of audits, Audit criteria, Audit process, Responsibilities of
stakeholders in audit process, Audit follow-up and documentation,
Audit resolution and Preparing for FDA inspections, Fraud and
misconduct management
Data Management:
Infrastructure and System Requirement for Data
Management: Electronic data capture systems, Selection and
implementation of new systems, System validation and test
procedures, Coding dictionaries, Data migration and archival
Clinical Trial Data Management: Standard Operating
Procedures, Data management plan, CRF & Data base design
considerations, Study set-up, Data entry, CRF tracking and
corrections, Data cleaning, Managing laboratory and ADR data,
Data transfer and database lock, Quality Control and Quality
Assurance in CDM, Data mining and warehousing.
References
1. Principles and practice of pharmaceutical medicine, Second edition.
Authors:Lionel. D. Edward, Aadrew.J.Flether Anthony W Fos , Peter D
Sloaier Publisher:Wiley;
2. Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill
Livingstone
3. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna
and Haynes.
4. Central Drugs Standard Control Organization. Good Clinical Practices-
Guidelines for Clinical Trials on Pharmaceutical Products in India. New
Delhi: Ministry of Health.
5. International Conference on Harmonisation of Technical requirements for
registration of Pharmaceuticals for human use. ICH Harmonised Tripartite
Guideline. Guideline for Good Clinical Practice.E6; May 1996.
6. Ethical Guidelines for Biomedical Research on Human Subjects. Indian
Council of Medical Research, New Delhi.
7. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan
Green, John Wiley and Sons.
8. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs.
Second Edition, Jan 2000, Wiley Publications.
9. Goodman & Gilman: JG Hardman, LE Limbard, McGraw Hill Publications.
140
PHARMACY PRACTICE PRACTICAL – I (MPP 105P)
Pharmacy Practice practical component includes experiments covering important

topics of the courses Clinical Pharmacy Practice, Pharmacotherapeutics-I, Hospital
& Community Pharmacy and Clinical Research.
List of Experiments (24)

1. Treatment Chart Review (one)
2. Medication History Interview (one)
3. Patient Medication Counseling (two)
4. Drug Information Query (two)
5. Poison Information Query (one)
6. Lab Data Interpretation (two)
7. Presentation of clinical cases of various disease conditions
adopting Pharmaceutical Care Plan Model (eight)
8. ABC Analysis of a given list of medications (one)
9. Preparation of content of a medicine, with proper justification,
for the inclusion in the hospital formulary (one)
10. Formulation and dispensing of a given IV admixtures (one)
11. Preparation of a patient information leaflet (two)
12. Preparation of Study Protocol (one)
13. Preparation of Informed Consent Form (one)
141
PRINCIPLES OF QUALITY USE OF MEDICINES (MPP 201T)
Scope:
This course is designed to impart basic knowledge and skills that are required to
practice quality use of medicines (QUM) in different healthcare settings and also to
promote quality use of medicines, in clinical practice, through evidence-based
medicine approach.
Course Outcome
CO1 Explain the principles of Quality Use of Medicines
CO2 Describe the Rational drug therapy
CO3 Practice Evidence based medicine
CO4 Describe the Quality Use of Medicine in various settings
CO5 Explain Quality Use of Medicines in special population
CO6 Recognize regulatory aspects of Quality Use of Medicines
CO7 Identify and resolve Medication errors
CO8 Evaluate, assess and monitor Adverse Drug Reactions

1 Introduction to Quality use of medicines (QUM): Definition and 12
Principles of QUM, Key partners and responsibilities of the
partners, Building blocks in QMC, Evaluation process in QMC,
Communication in QUM, Cost effective prescribing.
2 Concepts in QUM 12
Evidence based medicine: Definition, concept of evidence based
medicine, Approach and practice of evidence based medicine in
clinical settings
Essential drugs: Definition, need, concept of essential drug,
National essential drug policy and list
Rational drug use: Definition, concept and need for rational drug
use, Rational drug prescribing, Role of pharmacist in rational drug
use.
142
3 QUM in various settings: Hospital settings, Ambulatory 12

care/Residential care, Role of health care professionals in
promoting the QUM, Strategies to promote the QUM, Impact of
QUM on E-health, integrative medicine and multidisciplinary care.
QUM in special population: Pediatric prescribing, Geriatric
prescribing, Prescribing in pregnancy and lactation, Prescribing in
immune compromised and organ failure patients
4 Regulatory aspects of QUM in India: Regulation including 12

scheduling, Regulation of complementary medicines, Regulation
of OTC medicines, Professional responsibility of pharmacist,
Role of industry in QUM in medicine development
5 Medication errors: Definition, categorization and causes of 12
medication errors, Detection and prevention of medication errors,
Role of pharmacist in monitoring and management of medication
errors
Pharmacovigilance: Definition, aims and need for
pharmacovigilance, Types, predisposing factors and mechanism of
adverse drug reactions (ADRs), Detection, reporting and
monitoring of ADRs, Causality assessment of ADRs, Management
of ADRs, Role of pharmacist in pharmacovigilance.
References:
1. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills –
Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata
2. Andrews EB, Moore N. Mann’s Pharmacovigilance
3. Dipiro JT, Talbert RL, Yee GC. Pharmacotherapy: A Pathophysiologic
Approach
4. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based
Medicine: How to practice and teach it
5. Cohen MR. Medication Errors Online: http://medicinesaustralia.com.au/
files/2012/05/MA_QUM_External_Reduced.pdf
http://curriculum.racgp.org.au/statements/quality-use-of-medicines/
http://www.rug.nl/research/portal/files/14051541/Chapter_2.pdf
143
PHARMACOTHERAPEUTICS II (MPP 202T)
Scope
This course aims to enable the students to understand the different treatment
approaches in managing various disease conditions. Also, it imparts knowledge and
skills in optimizing drug therapy of a patient by individualizing the treatment plan
through evidence-based medicines.
Course Outcome
CO1 Describe the etiopathogenesis of selected disease states
CO2 Discuss the various methods involved in the diagnosis of selected disease
state
CO3 Interpret and analyze the selected laboratory results of specific disease
states
CO4 Describe the therapeutic approach to manage the selected diseases
CO5 Discuss the rationale for drug therapy of the selected disease
CO6 Identify the controversies in drug therapy
CO7 Develop the individualized therapeutic plans based on diagnosis
CO8 Identify the patient-specific parameters relevant in initiating the drug therapy

1 Nervous system: Epilepsy, Parkinson's disease, Stroke, Headache, 12
Alzheimer’s disease, Neuralgias and Pain pathways and Pain
management.
2 Psychiatric disorders: Schizophrenia, Depression, Anxiety 12
disorders, Sleep disorders, Drug induced psychiatric disorders Renal
system: Acute renal failure, Chronic renal failure, Renal dialysis,
Drug induced renal disease
3 Infectious diseases: General guidelines for the rational use of 12
antibiotics and surgical prophylaxis, Urinary tract infections,
Respiratory tract infections, Gastroenteritis, Tuberculosis, Malaria,
Bacterial endocarditis, Septicemia.
144
4 Infectious diseases: Meningitis, HIV and opportunistic infections, 12

Rheumatic fever, Dengue fever, H1N1, Helmenthiasis, Fungal
infections
Gynecological disorders: Dysmenorrhea, Hormone replacement
therapy.
5 Oncology: General principles of cancer chemotherapy, 12
pharmacotherapy of breast cancer, lung cancer, head & neck
cancer, hematological malignancies, Management of nausea and
vomiting, Palliative care
References
1. Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill
Livingstone publication.
2. Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach-
Appleton & Lange
3. Robins SL. Pathologic basis of disease -W.B. Saunders publication
4. Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and Wilkins
Publication
5. Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use
of Drugs- Lippincott Williams and Wilkins
6. Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro.
Pharmacotherapy Principles and practice-– McGraw Hill Publication
7. Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams and
Wilkins
8. Harrison's. Principles of Internal Medicine - McGraw Hill
145
CLINICAL PHARMACOKINETICS AND THERAPEUTIC DRUG

MONITORING (MPP 203T)
Scope
This course is designed to enable students to understand the basics principles and
applications of pharmacokinetics in designing the individualized dosage regimen, to
interpret the plasma drug concentration profile in altered pharmacokinetics, drug
interactions and in therapeutic drug monitoring processes to optimize the drug
dosage regimen. Also, it enables students to understand the basic concepts of
pharmacogenetics, pharmacometrics for modeling and simulation of
pharmacokinetic data.
Course Outcome
CO1 Formulate and design a dosage regimen for individual patients
CO2 Interpret and correlate the plasma drug concentration with patient’s
therapeutic outcomes
CO3 Recommend dosage adjustment in renal and hepatic disease
CO4 Recommend dosage adjustment for paediatrics and geriatrics
CO5 Analyze and resolvepharmacokintetic drug interactions
CO6 Illustrate and apply pharmacokinetic parameters in clinical settings
CO7 Interpret the impact of genetic poylmorphisms of individuals on
pharmacokinetics and pharmacodynamics of drugs
CO8 Employ pharmacokinetic modeling for the given data using the
principles of pharmacometrics

1 Introduction to Clinical pharmacokinetics: Compartmental and 12
Non compartmental models, Renal and non-renal clearance, Organ
extraction and models of hepatic clearance, Estimation and
determinants of bioavailability, Multiple dosing, Calculation of
loading and maintenance doses
Designing of dosage regimens: Determination of dose and dosing
intervals, Conversion from intravenous to oral dosing,
Nomograms and Tabulations in designing dosage regimen.
146
2 Pharmacokinetics of Drug Interaction: Pharmacokinetic drug 12

interactions, Inhibition and Induction of Drug metabolism,
Inhibition of Biliary Excretion
Pharmacogenetics: Genetic polymorphism in Drug metabolism:
Cytochrome P-450 Isoenzymes, Genetic Polymorphism in Drug
Transport and Drug Targets, Pharmacogenetics and
Pharmacokinetic / Pharmacodynamic considerations
Introduction to Pharmacometrics: Introduction to Bayesian
Theory, Adaptive method or Dosing with feedback, Analysis of
Population pharmacokinetic Data.
3 Non Linier Mixed Effects Modelling: The Structural or Base 12
Model, Modeling Random Effects, Modeling Covariate
Relationships, Mixture Model, Estimation Methods, Model
Building Techniques, Covariate Screening Methods, Testing the
model assumptions, Precision of the parameter estimates and
confidence intervals, Model misspecification and violation of the
model assumptions, Model Validation, Simulation of dosing
regimens and dosing recommendations, Pharmacometrics
software.
4 Altered Pharmacokinetics: Drug dosing in the elderly, Drug 12
dosing in the paediatrics, Drug dosing in the obese patients, Drug
dosing in the pregnancy and lactation, Drug dosing in the renal
failure and extracorporeal removal of drugs, Drug dosing in the in
hepatic failure.
5 Therapeutic Drug monitoring: Introduction, Individualization of 12
drug dosage regimen (Variability – Genetic, age, weight, disease
and Interacting drugs), Indications for TDM, Protocol for TDM,
Pharmacokinetic/Pharmacodynamic Correlation in drug therapy,
TDM of drugs used in the following conditions: Cardiovascular
disease: Digoxin, Lidocaine, Amiodarone; Seizure disorders:
Phenytoin, Carbamazepine, Sodium Valproate; Psychiatric
conditions: Lithium, Fluoxetine, Amitriptyline; Organ
transplantations: Cyclosporine; Cytotoxic Agents: Methotrexate,
5-FU, Cisplatin; Antibiotics: Vancomycin, Gentamicin,
Meropenem.
147
References
1. Leon Shargel, Susanna Wu-Pong, Andrew Yu. Applied Biopharmaceutics
& Pharmacokinetics. New York: Mc Graw Hill.
2. Peter L. Bonate. Pharmacokinetic - Pharmacodynamic Modeling and
Simulation. Springer Publications.
3. Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E.Evans.
Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic
Drug Monitoring. Iippincott Williams & Wilkins.
4. Steven How-Yan Wong, Irving Sunshine. Handbook of Analytical
Therapeutic Drug Monitoring and Toxicology. CRC Press, USA.
5. Soraya Dhillon, Andrzej Kostrzewski. Clinical pharmacokinetics. 1st
edition. London: Pharmaceutical Press.
6. Joseph T.Dipiro, William J.Spruill, William E.Wade, Robert A.Blouin and
Jane M.Pruemer .Concepts in Clinical Pharmacokinetics. American Society
of Health-System Pharmacists, USA.
7. Malcolm Rowland, Thomas N. Tozer .Clinical Pharmacokinetics and
pharmacodynamics: concepts and applications. Iippincott Williams &
Wilkins, USA.
8. Evans, Schentag, Jusko. Applied pharmacokinetics. American Society of
Health system Pharmacists, USA.
9. Michael E. Winter. Basic Clinical Pharmacokinetics. Iippincott Williams &
Wilkins, USA.
10. Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics. Pharma
Book Syndicate, USA.
11. Dhillon and Kostrzewski. Clinical pharmacokinetics. Pharmaceutical Press,
London.
12. John E .Murphy. Clinical Pharmacokinetics. 5th edition. US: American
Society of Health- System Pharmacist, USA.
148
PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS

(MPP 204T)
Scope
This course enables students to understand various pharmacoepidemiological
methods and their clinical applications. Also, it aims to impart knowledge on basic
concepts, assumptions, terminology, and methods associated with
Pharmacoeconomics and health related outcomes, and when should be appropriate
Pharmacoeconomic model should be applied for a health care regimen.
Course Outcome
At the end of the course students will be able to….
CO1 Identify the applications of pharmacoepidemiology and
pharmacoeconomics in clinical settings
CO2 Discuss the various pharmacoepidemiological outcome measures
CO3 Describe the concept of risk in pharmacoepidemiology and different
methods of measuring risk
CO4 Explain the various pharmacoepidemiological methods
CO5 Explain the various systems for studying drug effects in populations.
CO6 Discuss the methods to measure outcomes in pharmacoecnomic
studies
CO7 Describe the current pharmacoeconomic evaluation methods
CO8 Explain the pharmacoecnomic decision analysis methods and its
application

1 Introduction to Pharmacoepidemiology: Definition, Scope, Need, 12
Aims & Applications; Outcome measurement: Outcome measures,
Drug use measures: Monetary units, Number of prescriptions, units
of drug dispensed, defined daily doses, prescribed daily doses,
Diagnosis and Therapy surveys, Prevalence, Incidence rate,
Monetary units, number of prescriptions, unit of drugs dispensed,
defined daily doses and prescribed daily doses, medications
adherence measurements.
Concept of risk: Measurement of risk, Attributable risk and
relative risk, Time- risk relationship and odds ratio
149
2 Pharmacoepidemiological Methods: Qualitative models: 12

DrugUtilization Review; Quantitative models: case reports, case
series, Cross sectional studies, Cohort and case control studies,
Calculation of Odds’ ratio, Meta analysis models, Drug effects study
in populations: Spontaneous reporting, Prescription event
monitoring, Post marketing surveillance, Record linkage systems,
Applications of Pharmacoepidemiology
3 Introduction to Pharmacoeconomics: Definition, history of 12
Pharmacoeconomics, Need of Pharmacoeconomic studies in Indian
healthcare system.
Cost categorization and resources for cost estimation: Direct
costs. Indirect costs. Intangible costs.
Outcomes and Measurements of Pharmacoeconomics: Types of
outcomes: Clinical outcome, Economic outcomes, Humanistic
outcomes; Quality Adjusted Life Years, Disability Adjusted Life
Years Incremental Cost Effective Ratio, Average Cost Effective
Ratio. Person Time, Willingness To Pay, Time Trade Off and
Discounting.
4 Pharmacoeconomic evaluations: Definition, Steps involved, 12
Applications, Advantages and disadvantages of the following
Pharmacoeconomic models: Cost Minimization Analysis (CMA),
Cost Benefit Analysis (CBA), Cost Effective Analysis (CEA), Cost
Utility Analysis (CUA), Cost of Illness (COI), Cost Consequences
Analysis (COA).
5 Definition, Steps involved, Applications, Advantages and 12
disadvantages of the following:
Health related quality of life (HRQOL): Definition, Need for
measurement of HRQOL, Common HRQOL measures.
Definition, Steps involved, Applications of the following:
Decision Analysis and Decision tree, Sensitivity analysis, Markov
Modeling, Software used in pharmacoeconomic analysis,
Applications of Pharmacoeconomics.
150
References
1. Rascati K L. Essentials of Pharmacoeconomics, Kluw Woulters Lippincott
Williams & Wilkins, Philadelphia.
2. Thomas E Getzen. Health economics. Fundamentals and Flow of Funds.
John Wiley & Sons, USA.
3. Andrew Briggs, Karl Claxton, Mark Sculpher. Decision Modelling for
Health Economic Evaluation, Oxford University Press, London.
4. Michael Drummond, Mark Sculpher, George Torrence, Bernie O'Brien and
Greg Stoddart. Methods for the Economic Evaluation of Health Care
Programmes Oxford University Press, London.
5. George E Mackinnon III. Understanding health outcomes and
pharmacoeconomics.
6. Graker, Dennis. Pharmacoeconomics and outcomes.
7. Walley, Pharmacoeconomics.
8. Pharmacoeconomic – ed. by Nowakowska – University of Medical
Sciences, Poznan.
151
PHARMACY PRACTICE PRACTICAL - II (MPP 205P)
Pharmacy Practice practical component includes experiments covering important

topics of the courses Principles of Quality Use of Medicines, Pharmacotherapeutics-
II, Clinical Pharmacokinetics & Therapeutic Drug Monitoring and
Pharmacoepidemiology and Pharmacoeconomics.
List of Experiments (24)

1. Causality assessment of adverse drug reactions (three)
2. Detection and management of medication errors (three)
3. Rational use of medicines in special population (three)
4. Presentation of clinical cases of various disease conditions adopting
Pharmaceutical Care Plan Model (eight)
5. Calculation of Bioavailability and Bioequivalence from the given data (two)
6. Interpretation of Therapeutic Drug Monitoring reports of a given patient
(three)
7. Calculation of various Pharmacoeconomic outcome analysis for the given
data (two)
152
PHARMACOLOGY (MPL)
(MPL 101T)
Scope
Course Outcome
techniques
methods
CO6 Learn general principles and instrumentation of ion selective electrodes.
CO8 Explain Instrumentation, separation and identification of compounds by
electrophoresis technique.

1 a. UV-Visible spectroscopy: Introduction, Theory, Laws, 10
Instrumentation associated with UV-Visible spectroscopy,
Choice of solvents and solvent effect and Applications of UV-
Visible spectroscopy, Difference/ Derivative spectroscopy.
b. IR spectroscopy: Theory, Modes of Molecular vibrations,
Sample handling, Instrumentation of Dispersive and Fourier
- Transform IR Spectrometer, Factors affecting vibrational
frequencies and Applications of IR spectroscopy, Data
Interpretation.
c. Spectroflourimetry: Theory of Fluorescence, Factors
affecting fluorescence (Characterestics of drugs that can be
analysed by flourimetry), Quenchers, Instrumentation and
153
Applications of fluorescence spectrophotometer.

d. Flame emission spectroscopy and Atomic absorption
spectroscopy: Principle, Instrumentation, Interferences and
Applications.
2 NMR spectroscopy: Quantum numbers and their role in NMR, 10
Principle, Instrumentation, Solvent requirement in NMR,
Relaxation process, NMR signals in various compounds, Chemical
shift, Factors influencing chemical shift, Spin-Spin coupling,
Coupling constant, Nuclear magnetic double resonance,
Brief outline of principles of FT-NMR and 13C NMR.
Spectroscopy, Different types of ionization like electron impact,
chemical, field, FAB and MALDI, APCI, ESI, APPI Analyzers of
Quadrupole and Time of Flight, Mass fragmentation and its rules,
Meta stable ions, Isotopic peaks and Applications of Mass
spectroscopy.
4 Chromatography: Principle, apparatus, instrumentation, 10

chromatographic parameters, factors affecting resolution, isolation
of drug from excipients, data interpretation and applications of the
following:
154
5 a. Electrophoresis: Principle, Instrumentation, Working 10

conditions, factors affecting separation and applications of the
following:
b. X ray Crystallography: Production of X rays, Different X
ray methods, Bragg‘s law, Rotating crystal technique, X ray
powder technique, Types of crystals and applications of X-
ray diffraction.
6 a. Potentiometry: Principle, working, Ion selective Electrodes 10
and Application of potentiometry.
Instrumentation (Heat flux and power-compensation and
designs), Modulated DSC, Hyper DSC, experimental
parameters (sample preparation, experimental conditions,
calibration, heating and cooling rates, resolution, source of
errors) and their influence, advantage and disadvantages,
pharmaceutical applications. Differential Thermal Analysis
(DTA): Principle, instrumentation and advantage and
disadvantages, pharmaceutical applications, derivative
differential thermal analysis (DDTA). TGA: Principle,
instrumentation, factors affecting results, advantage and
disadvantages, pharmaceutical applications.
c. Immunological assays: RIA (Radio immuno assay),
ELISA, Bioluminescence assays.
References
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New Delhi, 1997.
155
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,

3rd Edition, CBS Publishers, New Delhi, 1997.
Delhi.
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley
& Sons, 1982.
156
ADVANCED PHARMACOLOGY - I (MPL 102T)
Scope
The subject is designed to strengthen the basic knowledge in the field of
pharmacology and to impart recent advances in the drugs used for the treatment of
various diseases. In addition, this subject helps the students to understand the
concepts of drug action and mechanisms involved
Course Outcome
CO1 Explain general pharmacological concepts such as pharmacodynamics and
pharmacokinetics
CO2 Explain the general concept of Neurotransmission, neuritransmitters and
drugs affecting it
CO3 Explain the Pharmacology of sympathetic and parasympathetic
neurotransmitters including their agonist and antagonist
CO4 Explain the different Classes of drugs used in various CNS disorders like
anxiety, depression, mania, psychosis, epilepsy, neurodegenerative diseases,
CO5 Describe the Pharmacology of general and local anesthetics
CO6 Classify & Explain the Pharmacology of narcotic and non narcotic
analgesics
CO7 Explain the Pharmacology of cardiovascular drugs such as diuretics, anti
hypertensives, anti ischemic, anti hyperlipidemic, drugs used in CCF,
hematinics, coagulants, anti coagulants, fibrinolytics and antiplatlet drugs
CO8 Describe the physiological and pathological role of histamine,5-
HT,Kinins,prostaglandins, opioid autacoids and Pharmacology of
antihistamines and 5-HT antagonist

1 General Pharmacology 12
a. Pharmacokinetics: The dynamics of drug absorption,
distribution, biotransformation and elimination. Concepts of
linear and non-linear compartment models. Significance of
Protein binding.
b. Pharmacodynamics: Mechanism of drug action and the
relationship between drug concentration and effect. Receptors,
structural and functional families of receptors, quantitation of
c. drug receptors interaction and elicited effects.
157
2 Neurotransmission 12
a. General aspects and steps involved in neurotransmission.
b. Neurohumoral transmission in autonomic nervous system
(Detailed study about neurotransmitters- Adrenaline and Acetyl
choline).
c. Neurohumoral transmission in central nervous system (Detailed
study about neurotransmitters- histamine, serotonin, dopamine,
GABA, glutamate and glycine].
d. Non adrenergic non cholinergic transmission (NANC).
Co- transmission
Systemic Pharmacology: A detailed study on pathophysiology of
diseases, mechanism of action, pharmacology and toxicology of
existing as well as novel drugs used in the following systems
Autonomic Pharmacology: Parasympathomimetics and lytics,
sympathomimetics and lytics, agents affecting neuromuscular
junction
3 Central nervous system Pharmacology 12
General and local anesthetics Sedatives and hypnotics, drugs used to
treat anxiety. Depression, psychosis, mania, epilepsy,
neurodegenerative diseases. Narcotic and non-narcotic analgesics.
4 Cardiovascular Pharmacology: Diuretics, antihypertensives, 12
antiischemics, anti-arrhythmics, drugs for heart failure and
hyperlipidemia. Hematinics, coagulants , anticoagulants, fibrinolytics
and anti- platelet drugs
5 Autocoid Pharmacology: The physiological and pathological role 12
of Histamine, Serotonin, Kinins Prostaglandins Opioid autocoids.
Pharmacology of antihistamines, 5HT antagonists.
References
1. The Pharmacological Basis of Therapeutics, Goodman and Gillman‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by
David E Golan, Armen H, Tashjian Jr, Ehrin J,Armstrong, April W,
Armstrong, Wolters, Kluwer- Lippincott Williams & Wilkins Publishers.
3. Basic and Clinical Pharmacology by B.G Katzung
4. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
5. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and
Andrew B.C.Yu.
6. Graham Smith. Oxford textbook of Clinical Pharmacology.
158
7. Avery Drug Treatment

8. Dipiro Pharmacology, Pathophysiological approach.
9. Green Pathophysiology for Pharmacists.
10. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology)
11. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava
published by APC Avichal Publishing Company
12. KD.Tripathi. Essentials of Medical Pharmacology.
13. Modern Pharmacology with Clinical Applications, Craig Charles R. & Stitzel
Robert E., Lippincott Publishers.
14. Clinical Pharmacokinetics & Pharmacodynamics: Concepts and Applications
– Malcolm Rowland and Thomas N.Tozer, Wolters Kluwer, Lippincott
Williams & Wilkins Publishers.
15. Applied biopharmaceutics and Pharmacokinetics, Pharmacodynamics and
Drug metabolism for industrial scientists.
16. Modern Pharmacology, Craig CR. & Stitzel RE, Little Brown & Company.
159
PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING

METHODS - I (MPL 103T)
Scope
This subject is designed to impart the knowledge on preclinical evaluation of drugs
and recent experimental techniques in the drug discovery and development. The
subject content helps the student to understand the maintenance of laboratory
animals as per the guidelines, basic knowledge of various in-vitro and in-vivo
preclinical evaluation processes
Course Outcome
CO1 Describe the regulations and ethical requirement for the usage of various
species and strains of experimental animals and explain CPCSEA
guidelines, GLP,
CO2 Classify Bioassay, Explain the principle, scope, limitations and methods
of bioassay
CO3 Classify and explain various preclinical invitro , invivo and other
possible animal alternative models for the screening of following classes
of drugs such as behavioral and muscle co ordination, CNS stimulants and
depressants, anxiolytics, anti-psychotics, anti epileptics and nootropics.
Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers and
multiple sclerosis. Drugs acting on Autonomic Nervous System.
of drugs such as Respiratory Pharmacology: anti-asthmatics, drugs for
COPD and anti allergics. Reproductive Pharmacology: Aphrodisiacs and
antifertility agents Analgesics, antiinflammatory and antipyretic agents.
Gastrointestinal drugs: anti ulcer, anti -emetic, anti-diarrheal and
laxatives.
of drugs such as Cardiovascular Pharmacology: antihypertensives,
antiarrythmics, antianginal, antiatherosclerotic agents and diuretics.
Drugs for metabolic disorders like anti-diabetic, antidyslipidemic agents.
Anti cancer agents. Hepatoprotective screening methods.
of drugs such as Iimmunomodulators, Immunosuppressants and
immunostimulants
160
CO7 Describe general principles of Immunoassay and explain Immunoassay

methods of evaluation
CO8 Describe limitations of animal experimentation , alternate animal
experiments and explain Extrapolation of in vitro data to preclinical and
preclinical to humans

1 Laboratory Animals: Common laboratory Description, 12
handling and animals: applications of different species and
strains of animals. Transgenic animals: Production,
maintenance and applications Anaesthesia and euthanasia of
experimental animals. Maintenance and breeding of laboratory
animals. CPCSEA guidelines to conduct experiments on
animals Good laboratory practice. Bioassay-Principle, Scope
and limitations and methods
2 Preclinical screening of new substances for the 12
pharmacological activity using in vivo, in vitro, and other
possible animal alternative models. General principles of
preclinical screening. CNS Pharmacology: behavioral and
muscle co-ordination, CNS stimulants and depressants,
anxiolytics, anti-psychotics, anti epileptics and nootropics.
Drugs for neurodegenerative diseases like Parkinsonism,
Alzheimers and multiple sclerosis. Drugs acting on Autonomic
Nervous System.
possible animal alternative models. Respiratory
Pharmacology: anti-asthmatics, drugs for COPD and anti
allergics. Reproductive Pharmacology: Aphrodisiacs and
antifertility agents Analgesics, antiinflammatory and antipyretic
agents. Gastrointestinal drugs: anti ulcer, anti-emetic, anti-
diarrheal and laxatives.
possible animal alternative models. Cardiovascular
Pharmacology: antihypertensives, antiarrythmics, antianginal,
antiatherosclerotic agents and diuretics. Drugs for metabolic
disorders like anti-diabetic, antidyslipidemic agents. Anti
161
cancer agents. Hepatoprotective screening methods.

possible animal alternative models. Iimmunomodulators,
Immunosuppressants and immunostimulants
General principles of immunoassay: theoretical basis and
optimization of immunoassay, heterogeneous and homogenous
immunoassay systems. Immunoassay methods evaluation;
protocol outline, Objectives and preparation. Immunoassay for
digoxin and insulin Limitations of animal experimentation and
alternate animal experiments. Extrapolation of in vitro data to
preclinical and preclinical to humans
References
1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin
2. Screening methods in Pharmacology by Robert Turner. A
3. Evaluation of drugs activities by Laurence and Bachrach
4. Methods in Pharmacology by Arnold Schwartz.
5. Fundamentals of experimental Pharmacology by M.N.Ghosh
6. Pharmacological experiment on intact preparations by Churchill
Livingstone
7. Drug discovery and Evaluation by Vogel H.G.
8. Experimental Pharmacology by R.K.Goyal.
9. Preclinical evaluation of new drugs by S.K. Guta
10. Handbook of Experimental Pharmacology, SK.Kulkarni
11. Practical Pharmacology and Clinical Pharmacy, SK.Kulkarni, 3rd Edition.
12. David R.Gross. Animal Models in Cardiovascular Research, 2nd Edition,
Kluwer Academic Publishers, London, UK.
13. Screening Methods in Pharmacology, Robert A.Turner.
14. Rodents for Pharmacological Experiments, Dr.Tapan Kumar chatterjee.
15. Practical Manual of Experimental and Clinical Pharmacology by Bikash
Medhi (Author), Ajay Prakash (Author)
162
CELLULAR AND MOLECULAR PHARMACOLOGY (MPL 104T)
Scope:
The subject imparts a fundamental knowledge on the structure and functions of
cellular components and help to understand the interaction of these components with
drugs. This information will further help the student to apply the knowledge in drug
discovery process.
Course Outcome
CO1 Explain cellular structure and functions and cell regulation
CO2 Describe molecular and cellular cell signaling pathways
CO3 Describe in detail Principles and applications of genomic and
proteomic tools
CO4 Principles ,applications and recent advances in gene therapy
CO5 Describe in detail Principles and applications of
Pharmacogenomics
CO6 Explain the Principles and applications of proteomics science
CO7 Describe in detail Principles and applications of
Immunotherapeutics
CO8 Describe Cell culture techniques and biosimilars

1 Cell biology: Structure and functions of cell and its organelles 12
Genome organization. Gene expression and its regulation,
importance of siRNA and micro RNA, gene mapping and gene
sequencing Cell cycles and its regulation. Cell death– events,
regulators, intrinsic and extrinsic pathways of apoptosis. Necrosis
and autophagy.
2 Cell signaling: Intercellular and intracellular signaling pathways. 12
Classification of receptor family and molecular structure ligand
gated ion channels; G-protein coupled receptors, tyrosine kinase
receptors and nuclear receptors. Secondary messengers: cyclic
AMP, cyclic GMP, calcium ion, inositol 1,4,5-trisphosphate, (IP3),
NO, and diacylglycerol. Detailed study of following intracellular
signaling pathways: cyclic AMP signaling pathway, mitogen-
activated protein kinase (MAPK) signaling, Janus kinase
163
(JAK)/signal transducer and activator of transcription (STAT)

signaling pathway.
3 Principles and applications of genomic and proteomic tools: 12
DNA electrophoresis, PCR (reverse transcription and real time),
Gene sequencing, micro array technique, SDS page, ELISA and
western blotting, Recombinant DNA technology and gene Basic
principles of recombinant DNA technology-Restriction therapy
enzymes, various types of vectors. Applications of recombinant
DNA technology. Gene therapy- Various types of gene transfer
techniques, clinical applications and recent advances in gene
therapy.
4 Pharmacogenomics: Gene mapping and cloning of disease gene. 12
Genetic variation and its role in health/ pharmacology
Polymorphisms affecting drug metabolism Genetic variation in
drug transporters Genetic variation in G protein coupled receptors
Applications of proteomics science: Genomics, proteomics,
metabolomics, functionomics, nutrigenomics
Immunotherapeutics: Types of immunotherapeutics,
humanisation antibody therapy, Immunotherapeutics in clinical
practice
5 a. Cell culture techniques: Basic equipments used in cell 12
culture lab. Cell culture media, various types of cell culture,
general procedure for cell cultures; isolation of cells,
subculture, cryopreservation, characterization of cells and
their application. Principles and applications of cell viability
assays, glucose uptake assay, Calcium influx assays
Principles and applications of flow cytometry
b. Biosimilars
References:
1. The Cell, A Molecular Approach. Geoffrey M Cooper.
2. Pharmacogenomics: The Search for Individualized Therapies. Edited by J.
Licinio and M -L. Wong
3. Handbook of Cell Signaling (Second Edition) Edited by Ralph A. et.al
4. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson
et.al
5. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller
164
6. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor)

7. Animal Cell Culture: A Practical Approach by John R. Masters (Editor)
8. Current porotocols in molecular biology vol I to VI edited by Frederick
M.Ausuvel et la.
165
PHARMACOLOGICAL PRACTICAL - I (MPL 105P)
1. Analysis of pharmacopoeial compounds and their formulations by UV

Vis spectrophotometer
Handling of laboratory animals

1. Various routes of drug administration.
2. Techniques of blood sampling, anesthesia and euthanasia of experimental
animals.
3. Functional observation battery tests (modified Irwin test)
4. Evaluation of CNS stimulant, depressant, anxiogenics and anxiolytic,
anticonvulsant activity.
5. Evaluation of analgesic, anti-inflammatory, local anesthetic, mydriatic and
miotic activity.
6. Evaluation of diuretic activity.
7. Evaluation of antiulcer activity by pylorus ligation method.
8. Oral glucose tolerance test.
9. Isolation and identification of DNA from various sources (Bacteria,
Cauliflower, onion, Goat liver).
10. Isolation of RNA from yeast
11. Estimation of proteins by Braford/Lowry’s in biological samples.
12. Estimation of RNA/DNA by UV Spectroscopy
13. Gene amplification by PCR.
14. Protein quantification Western Blotting.
15. Enzyme based in-vitro assays (MPO, AChEs, α amylase, α glucosidase).
16. Cell viability assays (MTT/Trypan blue/SRB).
17. DNA fragmentation assay by agarose gel electrophoresis.
18. DNA damage study by Comet assay.
19. Apoptosis determination by fluorescent imaging studies.
20. Pharmacokinetic studies and data analysis of drugs given by different
routes of administration using softwares
166
21. Enzyme inhibition and induction activity

22. Extraction of drug from various biological samples and estimation of drugs
in biological fluids using different analytical techniques (UV)
23. Extraction of drug from various biological samples and estimation of drugs
in biological fluids using different analytical techniques (HPLC)
References
1. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA guidelines,
2. Fundamentals of experimental Pharmacology by M.N.Ghosh
3. Handbook of Experimental Pharmacology by S.K. Kulkarni.
4. Drug discovery and Evaluation by Vogel H.G.
5. Spectrometric Identification of Organic compounds - Robert M
Silverstein,
Timothy A. Nieman,
7. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset,
Mendham, Denney,
8. Basic Cell Culture protocols by Cheril D. Helgason and Cindy L.Mille
9. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor)
10. Animal Cell Culture: A Practical Approach by John R. Masters (Editor)
11. Practical Manual of Experimental and Clinical Pharmacology by Bikash
Medhi(Author), Ajay Prakash (Author) Jaypee brothers’ medical
publishers Pvt. Ltd
167
ADVANCED PHARMACOLOGY - II (MPL 201T)
Scope
The subject is designed to strengthen the basic knowledge in the field of
pharmacology and to impart recent advances in the drugs used for the treatment of
various diseases. In addition, the subject helps the student to understand the concepts
of drug action and mechanism involved
Course Outcome
CO1 Describe the molecular and cellular mechanism of actions of
hormones and drugs affecting it
CO2 Describe the Pharmacological aspects of chemotherapeutic agents
CO3 Explain the concept of immunity and drugs affecting it
CO4 Describe the Pharmacological aspects of drugs affecting GI system
CO5 Explain the concept and applications of chronopharmacology
CO6 Describe the concept of free radicals , anti oxidants and their role in
various disordres
CO7 Explain the recent advancement in the treatment of Alzheimer’s
disease, Parkinson’s disease, Cancer, Diabetes mellitus
CO8 Explain the Pharmacotherapy of Asthma and COPD

1 Endocrine Pharmacology: Molecular and cellular mechanism of 12
action of hormones such as growth hormone, prolactin, thyroid,
insulin and sex hormones Anti-thyroid drugs, Oral hypoglycemic
agents, Oral contraceptives, Corticosteroids.
Drugs affecting calcium regulation
2 Chemotherapy: Cellular and molecular mechanism of actions and 12
resistance of antimicrobial agents such as ß-lactams,
aminoglycosides, quinolones, Macrolide antibiotics. Antifungal,
antiviral, and anti-TB drugs.
3 Chemotherapy: Drugs used in Protozoal Infections Drugs used in 12
the treatment of Helminthiasis Chemotherapy of cancer
Immunopharmacology: Cellular and biochemical mediators of
inflammation and immune response. Allergic or hypersensitivity
168
reactions. Pharmacotherapy of asthma and COPD.

Immunosuppressants and Immunostimulants
4 GIT Pharmacology: Antiulcer drugs, Prokinetics, antiemetics, anti- 12
diarrheals and drugs for constipation and irritable bowel syndrome.
Chronopharmacology: Biological and circadian rhythms,
applications of chronotherapy in various diseases like
cardiovascular disease, diabetes, asthma and peptic ulcer
5 Free radicals Pharmacology: Generation of free radicals, role of 12
free radicals in etiopathology of various diseases such as diabetes,
neurodegenerative diseases and cancer. Protective activity of certain
important antioxidant
Recent Advances in Treatment: Alzheimer’s disease, Parkinson’s
disease, Cancer, Diabetes mellitus
References
1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s
2. Principles of Pharmacology. The Pathophysiologic basis of drug therapy by
David E Golan et al.
3. Basic and Clinical Pharmacology by B.G -Katzung
4. Pharmacology by H.P. Rang and M.M. Dale.
5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, drug and disease management by E T. Herfindal
and Gourley.
Andrew B.C.Yu.
8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug
Metabolism for Industrial Scientists
9. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology)
10. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava
published by APC Avichal Publishing Company.
11. KD.Tripathi. Essentials of Medical Pharmacology
12. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by
David E Golan, Armen H, Tashjian Jr, Ehrin J,Armstrong, April W,
Armstrong, Wolters, Kluwer- Lippincott Williams & Wilkins Publishers
169
PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING

METHODS-II (MPL 202T)
Scope:
This subject imparts knowledge on the preclinical safety and toxicological
evaluation of drug & new chemical entity. This knowledge will make the student
competent in regulatory toxicological evaluation.
Course Outcome
CO1 Explain the basics and the types of toxicology
CO2 Describe the regulatory guidelines for conducting toxicological
studies
CO3 Explain various toxicity studies as per OECD guidelines
CO4 Describe special toxicity studies
CO5 Describe in detail about various methods employed in drug
discovery and development
CO6 Explain the concept of Safety pharmacology studies
CO7 Explain the Importance and applications of toxicokinetics
CO8 Explain Alternative methods to animal toxicity testing.

1 Basic definition and types of toxicology (general, mechanistic, 12
regulatory and descriptive) Regulatory guidelines for conducting
toxicity studies OECD, ICH, EPA and Schedule Y OECD
principles of Good laboratory practice (GLP) History, concept
and its importance in drug development
2 Acute, sub-acute and chronic- oral, dermal and inhalational studies 12
as per OECD guidelines. Acute eye irritation, skin sensitization,
dermal irritation & dermal toxicity studies. Test item
characterization- importance and methods in regulatory toxicology
studies
3 Reproductive toxicology studies, Male reproductive toxicity studies, 12
female reproductive studies (segment I and segment III),
teratogenecity studies (segment II) Genotoxicity studies (Ames
Test, in vitro and in vivo Micronucleus and Chromosomal
aberrations studies) In vivo carcinogenicity studies
170
4 IND enabling studies (IND studies)- Definition of IND, importance 12

of IND, industry perspective, list of studies needed for IND
submission. Safety pharmacology studies- origin, concepts and
importance of safety pharmacology. Tier1- CVS, CNS and
respiratory safety pharmacology, HERG assay.
Tier2- GI, renal and other studies
5 Toxicokinetics- Toxicokinetic evaluation in preclinical studies, 12
saturation kinetics Importance and applications of toxicokinetic
studies. Alternative methods to animal toxicity testing.
References
1. Hand book on GLP, Quality practices for regulated non-clinical research and
development(http://www.who.int/tdr/publications/documents/glphandbook.pdf).
2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules, 2005,
ministry of health and family welfare (department of health) New Delhi
3. Drugs from discovery to approval by Rick NG.
4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan
5. OECD test guidelines.
6. Principles of toxicology by Karen E. Stine, Thomas M. Brown.
7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of
Human Clinical Trials and Marketing Authorization for Pharmaceuticals
(http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinform
ation/guidances/ucm073246.pdf)
171
PRINCIPLES OF DRUG DISCOVERY (MPL 203T)
Scope:
The subject imparts basic knowledge of drug discovery process. This information
will make the student competent in drug discovery process
Course Outcome
CO1 Describe in detail about various stages involved in modern drug
discovery process
CO2 Explain the role of genomics, proteomics and bioinformatics in drug
discovery
CO3 Explain various targets for drug discovery.
CO4 Explain various lead seeking method and lead optimization
CO5 Describe in detail about the concept of Rational Drug Design
CO6 Explain the concept of molecular docking and its applications
CO7 Explain the concept of QSAR and QSAR statistical methods
CO8 Explain Rationale of prodrug design and practical consideration of
prodrug design

1 An overview of modern drug discovery process: Target 12
identification, target validation, lead identification and lead
Optimization. Economics of drug discovery. Target Discovery and
validation-Role of Genomics, Proteomics and Bioinformatics.
Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger
proteins. Role of transgenic animals in target validation.
2 Lead Identification- combinatorial chemistry & high 12

throughputscreening, in silico lead discovery techniques, Assay
development for hit identification. Protein structure Levels of
protein structure, Domains, motifs, and folds in protein structure.
Computational prediction of protein structure: Threading and
homology modeling methods. Application of NMR and
X- raycrystallography in protein structure prediction
172
3 Rational Drug Design Traditional vs rational drug design, 12

Methods followed in traditional drug design, High throughput
screening, Concepts of Rational Drug Design, Rational Drug
Design Methods: Structure and Pharmacophore based approaches
Virtual Screening techniques: Drug likeness screening, Concept
of pharmacophore mapping and pharmacophore based Screening,
4 Molecular docking: Rigid docking, flexible docking, manual 12
docking; Docking based screening. De novo drug design.
Quantitative analysis of Structure Activity Relationship History
and development of QSAR, SAR versus QSAR, Physicochemical
parameters, Hansch analysis, Fee Wilson analysis and relationship
between them.
5 QSAR Statistical methods – regression analysis, partial least 12
square analysis (PLS) and other multivariate statistical methods.
3D-QSAR approaches like COMFA and COMSIA
Prodrug design-Basic concept, Prodrugs to improve patient
acceptability, Drug solubility, Drug absorption and distribution,
site specific drug delivery and sustained drug action. Rationale of
prodrug design and practical consideration of prodrug design
References
1. MouldySioud. Target Discovery and Validation Reviews and Protocols:
Volume 2 Emerging Molecular Targetsand Treatment Options. 2007
Humana Press Inc.
2. Darryl León. Scott MarkelIn. Silico Technologies in Drug Target
Identification and Validation. 2006 by Taylor and Francis Group, LLC.
3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols.
Springer New York Dordrecht Heidelberg London.
4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods
and Principles in Medicinal Chemistry. Publisher Wiley-VCH
5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design.
Methods and Principles in Medicinal Chemistry. Publisher Wiley-VCH
6. Abby L. Parrill. M. Rami Reddy. Rational Drug Design. Novel Methodology
and Practical Applications. ACS Symposium Series; American Chemical
Society: Washington, DC, 1999.
7. J. Rick Turner. New drug development design, methodology and, analysis.
John Wiley & Sons, Inc., New Jersey.
173
CLINICAL RESEARCH AND PHARMACOVIGILANCE

(MPL 204T)
Scope:
This subject will provide a value addition and current requirement for the students
in clinical research and pharmacovigilance. It will teach the students on
conceptualizing, designing, conducting, managing and reporting of clinical trials.
This subject also focuses on global scenario of Pharmacovigilance in different
methods that can be used to generate safety data. It will teach the students in
developing drug safety data in Pre-clinical, Clinical phases of Drug development
and post market surveillance.
Course Outcome
CO1 Explain the regulatory requirements for conducting clinical trial
CO2 Describe in detail about various types of clinical trial designs
CO3 Explain the responsibilities of key players involved in clinical trials
CO4 Describe the documentational requirements for Clinical trials
CO5 Explain Adverse drug reaction and its management
CO6 Describe basic concepts, and establishment of Pharmacovigilence
CO7 Explain ADR reporting, methods and tools used in
Pharmacovigilence
CO8 Describe Pharmacoepidemiology, pharmacoeconomics and safety
pharmacology

1 Regulatory Perspectives of Clinical Trials: Origin and Principles 12
of International Conference on Harmonization - Good Clinical
Practice (ICH-GCP) guidelines
Ethical Committee: Institutional Review Board, Ethical Guidelines
for Biomedical Research and Human Participant- Schedule Y, ICMR
Informed Consent Process: Structure and content of an Informed
Consent Process Ethical principles governing informed consent
process
174
2 Clinical Trials: Types and Design Experimental Study- RCT and Non 12
RCT, Observation Study: Cohort, Case Control, Cross sectional
Clinical Trial Study Team Roles and responsibilities of Clinical Trial
Personnel: Investigator, Study Coordinator, Sponsor, Contract
Research Organization and its management
3 Clinical Trial Documentation- Guidelines to the preparation of 12
documents, Preparation of protocol, Investigator Brochure, Case
Report Forms, Clinical Study Report Clinical Trial Monitoring- Safety
Monitoring in CT
Adverse Drug Reactions: Definition and types. Detection and
Reporting methods. Severity and seriousness assessment.
Predictability and preventability assessment, Management of adverse
drug reactions; Terminologies of ADR.
4 Basic aspects, terminologies and establishment of 12
pharmacovigilance: History and progress of pharmacovigilance,
Significance of safety monitoring, Pharmacovigilance in India and
international aspects, WHO international drug monitoring
programme, WHO and Regulatory terminologies of ADR, evaluation
of medication safety, Establishing pharmacovigilance centres in
Hospitals, Industry and National programmes related to
pharmacovigilance. Roles and responsibilities in Pharmacovigilance
5 Methods, ADR reporting and tools used in Pharmacovigilance 12
International classification of diseases, International Non- proprietary
names for drugs, Passive and Active surveillance, Comparative
observational studies, Targeted clinical investigations and Vaccine
safety surveillance. Spontaneous reporting system and Reporting to
regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G
Pharmacovigilance, VigiFlow, Statistical methods for evaluating
medication safety data.
6 Pharmacoepidemiology, pharmacoeconomics, safety 12
pharmacology
References
1. Central Drugs Standard Control Organization- Good Clinical Practices,
Guidelines for Clinical Trials on Pharmaceutical Products in India. New
Delhi: Ministry of Health;2001.
2. International Conference on Harmonization of Technical requirements for
registration of Pharmaceuticals for human use. ICH Harmonized Tripartite
175
Guideline. Guideline for Good Clinical Practice.E6; May 1996.

3. Ethical Guidelines for Biomedical Research on Human Subjects 2000.
Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan
Green, March 2005, John Wiley and Sons.
5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs.
Second Edition, Jan 2000, Wiley Publications.
6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill
Livingstone.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna
and Haynes.
176
PHARMACOLOGICAL PRACTICAL - II (MPL 205P)
1. To record the DRC of agonist using suitable isolated tissues preparation.

2. To study the effects of antagonist/potentiating agents on DRC of agonist using
suitable isolated tissue preparation.
3. To determine to the strength of unknown sample by matching bioassay by using
suitable tissue preparation.
4. To determine to the strength of unknown sample by interpolation bioassay by
using suitable tissue preparation
5. To determine to the strength of unknown sample by bracketing bioassay by
using suitable tissue preparation
6. To determine to the strength of unknown sample by multiple point bioassay by
using suitable tissue preparation.
7. Estimation of PA2 values of various antagonists using suitable isolated tissue
preparations.
8. To study the effects of various drugs on isolated heart preparations
9. Recording of rat BP, heart rate and ECG.
10. Recording of rat ECG
11. Drug absorption studies by averted rat ileum preparation.
12. Acute oral toxicity studies as per OECD guidelines.
13. Acute dermal toxicity studies as per OECD guidelines.
14. Repeated dose toxicity studies- Serum biochemical, haematological, urine
analysis, functional observation tests and histological studies.
15. Drug mutagenicity study using mice bone-marrow chromosomal aberration test.
16. Protocol design for clinical trial.(3 Nos.)
17. Design of ADR monitoring protocol.
18. In-silico docking studies. (2 Nos.)
19. In-silico pharmacophore based screening.
20. In-silico QSAR studies.
21. ADR reporting
References
1. Fundamentals of experimental Pharmacology-by M.N.Ghosh
2. Hand book of Experimental Pharmacology-S.K.Kulakarni
3. Text book of in-vitro practical Pharmacology by Ian Kitchen
177
4. Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal

choudhary and William Thomsen
Andrew B.C.Yu.
6. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug
Metabolism for Industrial Scientists.
178
Semester III
MRM 301T - Research Methodology & Biostatistics
Course Outcome
CO1 Learn general research methodology
CO2 Understand the basic concepts of biostatistics
CO3 Learn different parametric and non-parametric tests
CO4 Understand the functions of ethics committees in medical
research
CO5 Learn the guidelines for developing animal facilities
CO6 Explain the guidelines and importance of medical research
CO7 Learn the guidelines for the experimentation on animals
CO8 Understand the genesis of bioethics with special reference to
Helsinkl declaration
UNIT – I
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
UNIT – II
Biostatistics: Definition, application, sample size, importance of sample size,
factors influencing sample size, dropouts, statistical tests of significance, type of
significance tests, parametric tests (students “t” test, ANOVA, Correlation
coefficient, regression), non- parametric tests (wilcoxan rank tests, analysis of
variance, correlation, chi square test), null hypothesis, P values, degree of freedom,
interpretation of P values.
UNIT – III
Medical Research: History, values in medical ethics, autonomy, beneficence, non-
maleficence, double effect, conflicts between autonomy and beneficence/non-
maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox
medical ethics, importance of communication, control resolution, guidelines, ethics
committees, cultural concerns, truth telling, online business practices, conflicts of
interest, referral, vendor relationships, treatment of family members, sexual
relationships, fatality.
179
UNIT – IV
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care,
quarantine, surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical
facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
UNIT – V
Declaration of Helsinki: History, introduction, basic principles for all medical
research, and additional principles for medical research combined with medical care.
180

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Regulations and Curriculum for

(Deemed to be University under Section 3 of UGC Act, 1956)

To build a humane society through excellence in education and healthcare

Re-admission after break of study

Shastri Bhavan, New Delhi

1. Whereas the Central Government is empowered under Section 3 of the

(True Extract of the Notification)

No. F.26-5/2008(CPP-1) Dated: 24th March, 2009

1. Whereas the Government of India, Ministry of Human Resource

(True Extract of the Office Memorandum)

Ref. No. NU/REG/AC/2016-17/655 Date: 20.03.2017

Subject: Regulations and Curriculum pertaining to Master of Pharmacy

Ref: NU/REG/AC-NGSMIPS/2018-19/371 Date: 01.12.2018

Sub: Guidelines for the change of pharmacy PG specialization.

University Enclave, Medical Sciences Complex, T 0824-2204300/01/02/03 E reg@nitte.edu.in

(Deemed to be University under Section 3 of UGC Act, 1956)

Regulations and Curriculum for

Council or the Board of Management from time to time and shall be

credits taken during that semester. It shall be expressed up to two decimal

3. Minimum qualification for admission

4. Duration of the program

5. Medium of instruction and examinations

6. Maximum Period for completion of the course:

7. Selection of eligible candidates:

8. Withdrawal – Temporary and Permanent:

9. Conduct and discipline:

9.3.9. Any other act of gross indiscipline as decided by the Board of

10. Working days in each semester:

11. Attendance and Monitoring Progress of Students:

the period of registration.

12 Program/Course credit structure:

is dependent on the number of hours of instruction per week in that

The contact hours of seminars, assignments and research work shall be

Table – 1: List of M.Pharm. Specializations and their Code

Table – 2: Course of study for M. Pharm. (Pharmaceutics)

MPH202T Advanced Biopharmaceutics &

Table – 3: Course of study for M. Pharm. (Pharmaceutical Chemistry)

MPC104T Chemistry of Natural Products 4 4 4 100

Table – 4: Course of study for M. Pharm. (Pharmaceutical Quality Assurance)

Table – 5: Course of study for M. Pharm. (Pharmaceutical Regulatory Affairs)

Table – 6: Course of study for M. Pharm. (Pharmacy Practice)

Table – 7: Course of study for M. Pharm. (Pharmacology)

Table 9: Course of Study for M.Pharm IV Semester (Common for all

Table 10: Semester Wise Credit Distribution

3. Academic Award /Research Award from State 10 Award certificate

13. Involvement in guiding the junior students by 05 Certification by the

Note: International Conference: Held outside India

students at the beginning of respective semesters.

MPH202T Advanced 10 15 1 Hr 25 75 3 Hrs 100

MPC203T Computer Aided 10 15 1 Hr 25 75 3 Hrs 100

MQA203T Audits and 10 15 1 Hr 25 75 3 Hrs 100

MPL202T Pharmacological and 10 15 1 Hr 25 75 3 Hrs 100

16.2 Internal Assessment: Continuous Mode

Table 19: Scheme for awarding internal assessment: Continuous Mode

Table 20: Guidelines for the allotment of marks for attendance

16.2.1 Sessional Exams

Scheme for awarding internal assessment in continuous mode

17. Promotion and award of grades:

M Pharm Regulation & Syllabus

M Pharm Regulation & Syllabus

M Pharm Regulation & Syllabus